510(k) Premarket Notification
Shopping for a high-performing mask is a daunting task and claims of FDA approval would certainly make life easier but, spoiler alert, there’s no such thing as “FDA-approved” masks! There are however a number of FDA hoops that manufacturers can jump through to indicate some degree of quality and performance.
Surgical face masks are regulated as Class II Medical devices with FDA device code FXX. Surgical face masks require FDA 510k clearance to market in the USA. After getting 510k clearance, the manufacturing establishment must register with FDA and list the surgical mask with FDA using the cleared 510k number.
Face masks: A mask, with or without a face shield, covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. Face masks should be used by the general public and health care personnel as source control in accordance with CDC.
Surgical masks: A mask intended for medical purposes that cover the user's nose and mouth and provides a physical barrier to fluids and particulate materials. Surgical masks are Class II medical devices. These masks meet certain fluid barrier protection standards and flammability requirements. Surgical masks are also tested for particulate and bacterial filtration efficiencies and biocompatibility and are considered personal protective equipment (PPE).
The FDA regulates face masks as medical devices when they are intended for medical purposes. Face masks marketed to the public for non-medical use, such as industrial and gardening activities, are not regulated by FDA.
FDA Classification for Medical Masks
| Maximum Marketing Designation* | Medical Device Class | FDA Submission Type | Mask Information | ||
| Recommended Standard | Description | Product Code | |||
| FDA-Cleared | II | 510(k) | ASTM F2100, ASTM F2101, ASTM F1862 | Mask, Surgical | FXX |
| Surgical mask with antimicrobial/antiviral agent | OUK | ||||
| Pediatric/Child Facemask | OXZ | ||||
| FDA-Authorized | Not Classified | EUA | See EUA | Mask, Surgical, Eua Authorized | QMF |
| FDA-Listed | Not Classified | Enforcement Discretion** | ASTM F3502 | Face Mask Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency | QKR |
FDA-Cleared Masks
FDA-Authorized Masks
FDA-Listed Masks
|
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| 510(K) NUMBER | PRODUCT | COMPANY | APPROVAL DATE |
|---|---|---|---|
| K001892 | WHITE KNIGHT MASKS (21 MODELS VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS) | WHITE KNIGHT HEALTHCARE INC. | 2001/4/3 |
| K001893 | WHITE KNIGHT MASKS BLUE PINK YELLOW WHITE MASKS (13 MODELS) | WHITE KNIGHT HEALTHCARE INC. | 2001/4/2 |
| K001951 | PRIMED PLEATED TIE-BACK PROCEDURE MASK PM4-305 PRIMED PLEATED EAR-LOOP PROCEDURE MASK PM4-306 | PRIMELINE MEDICAL PRODUCTS INC. | 2000/9/8 |
| K001997 | WHITE KNIGHT BLUE GREEN FACE MASK (4 MODELS) | WHITE KNIGHT HEALTHCARE INC. | 2001/4/2 |
| K011789 | PROCEDURE MASKS: PM4-301 AND PM4-304 | PRIMELINE MEDICAL PRODUCTS INC. | 2001/6/22 |
| K012602 | CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE PINK CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE PINK WHITE GREEN. CROSSTEX | CROSSTEX INTL. | 2002/1/22 |
| K021076 | PRIMAGARD YELLOW SURGICAL MASK PLEATED TIE-ON PM4-307; PRIMAGARD YELLOW SURGICAL MASK PLEATED EAR-LOOPPM4-308; PRM | PRIMELINE MEDICAL PRODUCTS INC. | 2002/4/16 |
| K021533 | DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN BLUE YELLOW PINK WHITE) | CREATIVE CONTRACT (M) SDN BHD | 2003/3/5 |
| K021539 | DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS | CREATIVE CONTRACT (M) SDN BHD | 2003/3/5 |
| K021546 | DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR | CREATIVE CONTRACT (M) SDN BHD | 2003/3/5 |
| K022256 | SURGICAL FACE MASK - COLORS: WHITE YELLOW PINK BLUE AND GREEN | TUCKER & ASSOCIATES | 2004/4/26 |
| K023755 | WINNER EAR LOOP PROCEDURE MASK TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD | WINNER INDUSTRIES (SHENZHEN) CO. LTD. | 2003/6/10 |
| K030239 | MEGATECH SCIENTIFIC FACE MASK | MEGATECH SCIENTIFIC PTE LTD | 2003/7/24 |
| K031353 | SOLUTION FACE MASKS | A PLUS INTERNATIONAL INC | 2003/6/19 |
| K034015 | EARLOOP PROCEDURE MASK | MEDIPACK MEDICAL PACKAGING MFG. CO. | 2004/2/20 |
| K040333 | VALUMAX SURGICAL MASKS (BLUE PINK GREEN YELLOW WHITE AND PEACH) WITH OR WITHOUT VISORS TIES AND EARLOOPS | VALUMAX INTL. INC. | 2004/6/7 |
| K041047 | ULTRADENT CARBON MASK - UPI #342 | MEDSPRING GROUP INCORPORATED | 2004/12/1 |
| K042654 | PROTECTION PLUS EARLOOP PROCEDURE MASK | SAFETY-MED PRODUCTS INC. | 2004/12/17 |
| K043199 | SURGICAL FACE MASK | HONG YA NON-WOVEN PRODUCTS CO. LTD. | 2005/2/16 |
| K050689 | SURGICAL FACE MASK | CHINA SURGICAL DRESSINGS CENTER CO.LTD | 2005/10/26 |
| K051291 | NON-STERILE SURGICAL MASK | A.R. MEDICOM INC. | 2005/9/20 |
| K060776 | SURGICAL FACE MASK | HONG YA NON-WOVEN PRODUCTS CO. LTD. | 2006/5/25 |
| K061716 | PRESTIGE AMERITECH FACE MASK | Prestige Ameritech | 2006/8/14 |
| K061864 | DUKAL SURGICAL FACE MASK TIE-ON MODEL 1530; EAR LOOP MODEL 1540; WITH SHIELD MODEL 1560 | DUKAL CORP. | 2006/9/15 |
| K063043 | SURGICAL FACE MASK TYPE: TIE-ON EAR-LOOP | MODERN HEALTHCARE CORP. | 2007/3/21 |
| K070407 | DUKAL SURGICAL FACE MASK TIE EAR LOOP WITH SHIELD YELLOW & WHITE; ANTI FOG TIE LOOP SHIELD YELLOW WHITE AND BLUE | DUKAL CORP. | 2007/3/26 |
| K081633 | PRIMAGARD 80 120 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS | PRIMED MEDICAL PRODUCTS INC. | 2008/8/11 |
| K082258 | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR | CROSSTEX INTERNATIONAL | 2008/10/16 |
| K090131 | DS N95 SURGICAL MASKS AND FLAT SURGICAL | SHANGHAI DASHENG HEALTH PRODUCTS | 2009/4/27 |
| K092012 | PRIMAGARD DELTA FIT 80120 160 SURGICAL FACE MASK (SMALL MEDIUM LARGE) MODEL PG4-7061-7071-7081 PG4-7062 7072-70 | PRIMED MEDICAL PRODUCTS INC. | 2009/9/25 |
| K092580 | TIDI FACEMASK | TIDI PRODUCTSLLC | 2010/2/23 |
| K093179 | MEDICAL SURGICAL MASK (HH1001) RESPIRATORY MASK (HH1002) | H&H RESEARCH COMPANY | 2010/7/14 |
| K093901 | SURGICAL FACE MASK | EPARD PROTECTIVE PRODUCTS LTD | 2010/9/10 |
| K100800 | TIDI FACEMASK | TIDI PRODUCTS LLC | 2010/6/14 |
| K100846 | IMC SURGICAL FACE MASK | INTERNATIONAL MEDSURG CONNECTION | 2010/8/16 |
| K101000 | WELLMIEN SURGICAL MASK | WELLMIEN (SUZHOU) IMPORT & EXPORT TRADING CO. LTD | 2010/8/9 |
| K102713 | TIGER FLAT SURGICAL MASK | TIGER MEDICAL PRODUCTS LTD | 2011/1/25 |
| K103303 | CROSSTEX SURGICAL EARLOOP MASK- WHITE CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE NO FOG MASK WITH SPLASH VISOR-WHITE | CROSSTEX INTERNATIONAL INC. | 2010/12/23 |
| K110027 | SURGICAL FACE MASK; SURGICAL FACE MASK | ANGELINE GROUP LTD. | 2011/8/5 |
| K110455 | KIMBERLY-CLARK LOW BARRIER ASTM 2100 FACE MASKS | KIMBERLY-CLARK CORP. | 2011/4/29 |
| K110724 | SURGICAL PROCEDURE PACKS | OMNIA SPA | 2011/6/23 |
| K111343 | CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE CROSS | CROSSTEX INTERNATIONAL INC. | 2011/10/6 |
| K111402 | KC200 SURGICAL MASK KC200 PROCEDURE MASK KC300 SURGICALMASK FLUIDSHIELD KC300 PROCEDURE MASK FLUIDSHIELD MODEL | KIMBERLY-CLARK | 2011/10/20 |
| K111559 | SURGICAL MASKS | SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO. LTD. | 2011/9/16 |
| K122717 | FACE MASK SURGICAL MASK PROCEDURE MASK SURGICAL FACE MASK | TIGER MEDICAL PRODUCTS LTD | 2012/12/21 |
| K123115 | ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P | ACME FILTER MASK INC. | 2013/5/20 |
| K123787 | GREENCROSS SURGICAL MASK | JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.L | 2013/7/17 |
| K131879 | KC 300 SURGICAL MASK | KIMBERLY-CLARK CORP. | 2013/12/20 |
| K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | B.H. MEDICAL PRODUCTS CO. LTD. | 2015/6/22 |
| K140155 | SECURE-GARD SURGICAL AND PROCEDURE FACE MASK | CARDINAL HEALTH 200 LLC | 2014/6/20 |
| K141085 | WestTec Procedure Facemask;WestTec Surgical Facemask | WESTTEC LLC | 2015/3/27 |
| K141875 | Pasture 60S Surgical Mask | PASTURE PHARMA PTE LTD | 2015/5/5 |
| K142990 | Insta-Gard Surgical and Procedure Face Mask | Cardinal Health 200 LLC | 2015/3/4 |
| K143287 | Fluidshield* Surgical Mask with Expanded Chamber | Halyard Health Inc. | 2015/3/24 |
| K152197 | Skypro SP01 Mask | Skypro Medical Supplies Company | 2016/8/26 |
| K152561 | Communicator Surgical Facemask with Clear Window | Prestige Ameritech Ltd | 2016/6/3 |
| K153409 | Protect U Guard Earloop and Tie-On Mask (Blue White or Green) | PROTECT U GUARD LLC | 2016/11/15 |
| K153496 | Disposable Surgical Face Mask | XIANTAO RAYXIN MEDICAL PRODUCTS CO. LTD. | 2016/6/15 |
| K160269 | Surgical Face Masks (Ear loops and Tie-on) | SAN-M PACKAGE CO. LTD. | 2016/9/6 |
| K171162 | Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield | Prestige Ameritech | 2017/8/15 |
| K172500 | Technoweb Surgical Mask | YTS GLOBAL INC. | 2018/3/1 |
| K173062 | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) | V&Q Manufacturing Corporation | 2018/1/25 |
| K180874 | 3M High Performance Surgical Mask 3M High Performance Surgical Mask with Face Shield | 3M Health Care | 2018/7/31 |
| K182514 | Surgical Face Mask | Xiantao Zhibo Non-woven Products Co. Ltd | 2019/1/24 |
| K182515 | Surgical Face Mask | Wuhan Dymex Healthcare Co. Ltd | 2019/5/27 |
| K191355 | 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask | 3M Health Care | 2019/9/11 |
| K192374 | Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip | Cardinal Health 200 LLC | 2019/12/2 |
| K200576 | ClearMask Transparent Surgical Face Mask | ClearMask LLC | 2020/4/6 |
| K200847 | Surgical Face Mask | Mexpo International Inc. | 2020/4/23 |
| K200923 | Single-use Surgical Mask | BYD Precision Manufacturer Co.Ltd. | 2020/8/26 |
| K201095 | Sovereign America Surgical Face Mask | HomTex Inc. | 2021/3/19 |
| K201127 | DEFEND Ear-loop Face Masks | Young Dental Manufacturing Co. 1 LLC | 2021/4/14 |
| K201137 | Asept Surgical Face Mask | PFM Medical Inc | 2020/8/19 |
| K201182 | iMask Disposable Surgical Face Mask | Pac-Dent Inc. | 2021/2/19 |
| K201380 | Livocare Surgical Mask | Andon Health Co. Ltd. | 2020/10/7 |
| K201421 | Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons | Dukal Corporation | 2021/2/5 |
| K201470 | Disposable Medical Face Mask | JKH USA LLC | 2020/9/8 |
| K201479 | DemeMASK | DemeTECH Corporation | 2020/7/24 |
| K201517 | Plain Surgical Mask | AOK Tooling Limited | 2020/9/4 |
| K201537 | Protective Face Mask for Medical Use | Shandong Shengquan New Material Co. Ltd. | 2020/9/4 |
| K201545 | Surgical Face Mask | Amphastar Nanjing Pharmaceuticals Inc. | 2021/2/12 |
| K201549 | Motex Anti-Fog Surgical Face Mask | Modern Healthcare Corp. | 2020/8/26 |
| K201601 | Medical Face Mask | Shanghai Kindly Medical Instruments Co. Ltd. | 2020/11/10 |
| K201622 | Medical surgical mask | Guangdong KINGFA Sci.&Tech.Co.Ltd. | 2020/11/24 |
| K201624 | Spin Care Disposable Protective Mask | SpinTech LLC | 2021/3/18 |
| K201625 | Disposable Medical Surgical Mask | Tianjin Saiyuan Technology CO. LTD | 2021/1/12 |
| K201629 | Medical Face Mask | Shandong Shengquan New Material Co. Ltd. | 2020/12/14 |
| K201691 | Single-Use Surgical Mask With Ear Loop | Qiqihar Hengxin Medical Supplies Ltd. | 2020/9/17 |
| K201698 | Medical Surgical Mask | Hangzhou Mycode Bio-Medicine Co. Ltd. | 2021/3/15 |
| K201718 | GD Disposable Medical Face Mask | Jiangsu Guangda Medical Material Group Co. Ltd. | 2021/4/15 |
| K201729 | Medical Mask | Zhende Medical Co. Ltd | 2020/12/3 |
| K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop Dukal Corporation Level 3 Surgical Face Masks with Tie On | Dukal Corporation | 2021/2/16 |
| K201754 | JianYu Surgical Mask | Jiangsu JianYu Health Medical Co. Ltd. | 2020/12/30 |
| K201844 | Surgical Face Mask Surgical Mask | Lear Corporation | 2021/7/14 |
| K201852 | Surgical Mask-Model Number: Ear Loop Flat-Pleated | Huizhou Foryou Medical Devices Co. Ltd | 2021/3/2 |
| K201853 | Naton Disposable Surgical Face Mask | Naton Biotechnology (Beijing) Co. Ltd. | 2021/4/23 |
| K201868 | Phyziofit Medical Surgical Mask | Wellpower Sporting Goods Co. Ltd | 2021/2/22 |
| K201871 | Surgical Mask | C & S Paper Yunfu Co. Ltd. | 2020/8/12 |
| K201893 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co. LTD | 2020/12/9 |
| K201896 | ivi N3003 Surgical face Mask ivi N6006 Surgical mask | IOB Medical Inc | 2021/3/30 |
| K201924 | Single-Use Surgical Mask | Qiqihar Hengxin Medical Supplies Ltd. | 2021/3/15 |
| K201974 | Single-use medical face mask | Guangdong Horigen Mother & Baby Products Co. Ltd | 2021/3/7 |
| K201991 | Medical surgical mask | Shenzhen Everwin Precision Technology Co. Ltd. | 2020/11/23 |
| K202029 | Medical Surgical Mask | Beijing Biosis Healing Biological Technology Co. Ltd | 2020/12/16 |
| K202061 | Medical Face mask | Jiangsu Province Jianerkang Medical Dressing Co. Ltd | 2020/12/23 |
| K202069 | BASE4 Disposable Medical Mask | Base4 Group Inc. | 2020/12/1 |
| K202096 | 3-ply EcoGuard B with Earloop 3-ply EcoGuard B with Tie-On | EcoGuard Inc. | 2021/2/2 |
| K202107 | Medical Protective Mask | Guangdong Kingfa Sci.&Tech.Co. Ltd. | 2021/1/15 |
| K202126 | Disposable Surgical Mask | Shenzhen Peninsula Medical Co. Ltd | 2021/6/8 |
| K202128 | Allmed Surgical Face Masks (Ear loops) | Allmed Medical Products Co. LTD | 2021/6/3 |
| K202133 | Disposable Medical Mask | Hangzhou Qianzhiya Sanitary Products Co. Ltd | 2021/3/25 |
| K202137 | Disposable medical mask | U-Play Products Corporation | 2021/3/4 |
| K202139 | Medical surgical mask | Guangdong Kingfa SCI.&Tech.Co. Ltd. | 2020/11/20 |
| K202161 | Surgical Face Mask | Hunan EEXI Technology & Service Co. Ltd. | 2021/3/10 |
| K202191 | Surgical Mask | Wuhan Zonsen Medical Products Co. Ltd | 2021/3/29 |
| K202205 | Surgical Face Mask | Jiangsu Micsafe Medical Technology Co. Ltd | 2021/3/9 |
| K202211 | Disposable Medical Surgical Face Masks | Guangdong Kaidi Garments Co.Ltd | 2020/12/22 |
| K202214 | IFM Surgical Mask Model SM3 | FSSC LLC | 2021/3/2 |
| K202240 | Disposable Surgical Mask/Fluid Resistant Procedure Mask | LHM Medical Technology (Hong Kong) Limited | 2021/2/25 |
| K202255 | Skypro SP02 Mask (3) | Skypro Medical Supplies Company | 2021/12/24 |
| K202277 | Surgical Face Mask | Jiangxi 3L Medical Products Group Co. Ltd | 2020/9/25 |
| K202314 | Procedure face mask (Model: KKF-2A) | Han Zhaoqing Sporting Goods Company Limited | 2021/1/13 |
| K202316 | Medical mask (Model: KKF-1A) | Han Zhaoqing Sporting Goods Company Limited | 2021/3/3 |
| K202323 | Disposable Medical Surgical Masks | Tianjin Teda Jinshan Easy Packing Manufacture Co. LTD | 2021/2/2 |
| K202331 | Medical Face Mask | Gemtier Medical (Shanghai) Inc | 2021/2/2 |
| K202341 | Disposable Surgical Mask | Shanghai Jianzhong Medical Packaging Co. Ltd. | 2021/2/12 |
| K202354 | Surgical Mask-Model Number CW01 | Hunan Heng Chang Pharmaceutical Co. Ltd. | 2020/9/8 |
| K202358 | Protective Face Mask for Medical Use | Hunan Heng Chang Pharmaceutical Co. Ltd. | 2021/1/29 |
| K202387 | Disposable Surgical Face Mask | Guangdong Bida Medical Technology Co. Ltd. | 2021/4/23 |
| K202409 | Surgical Mask | Allmed Medical Products Co. Ltd. | 2021/3/9 |
| K202411 | Surgical Mask | Allmed Medical Products Co. Ltd. | 2021/3/10 |
| K202424 | Surgical Mask-Models CR02-2 CR02 | Foshan Xinbao Technology Co. Ltd. | 2021/3/31 |
| K202439 | Disposable Medical Face Mask | Hunan EEXI Technology & Service Co.Ltd. | 2021/3/8 |
| K202457 | M1 Surgical Face Mask | CHISON Medical Technologies Co. Ltd. | 2021/4/29 |
| K202463 | Disposable Surgical Mask | Unisources Group LLC | 2020/9/18 |
| K202491 | Disposable Surgical Face Mask | Jiangsu NewValue Medical Products Co. Ltd. | 2021/1/6 |
| K202493 | Medical Face Mask | Gemtier Medical (Shanghai) Inc | 2021/2/4 |
| K202511 | Disposable Medical Surgical Mask | Improve Medical (HuNan) Co. Ltd. | 2021/2/2 |
| K202513 | Disposable Medical Face Mask-Model FM-04 | Shenzhen Jinko Industrial Co. Ltd | 2021/4/9 |
| K202548 | Surgical Face Mask | Wanxinda (Guangzhou) Technology Product Co. Ltd | 2021/3/10 |
| K202577 | Medical Surgical Mask-Model MP002-5 MP002-6 | Jiangmen Sure&Me Medical Product CO. LTD | 2021/1/11 |
| K202580 | Disposable Surgical Mask | Qingdao Likangyuan Medical Device Co. Ltd. | 2021/6/7 |
| K202594 | Medical Surgical Masks-Non Sterile | Shandong T&F Nonwoven Co. LTD | 2021/1/6 |
| K202595 | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask | Premier Guard USA LLC | 2021/1/21 |
| K202598 | 3 Layer Surgical Mask with Ear Loops Level 1 3 Layer Surgical Mask with Ties Level 1 3 Layer Surgical Mask with Ear Loops Level 2 3 Layer Surgical Mask with Ties Level 2 3 Layer Surgical Mask with Ear Loops Level 3 3 Layer Surgical Marks with Ties Level 3 | 3A Medical Products Co. Ltd | 2021/5/6 |
| K202605 | Standard Procedure Mask Standard Surgical Mask | Jiangsu Medplus Non-woven Manufacturer Co. Ltd. | 2021/2/10 |
| K202607 | Surgical Mask - Level 3 - Blue - 50 pcs Surgical Mask - Level 3 - White - 50 pcs Procedure Mask - Level 3 - Blue - 50 pcs Procedure Mask - Level 3 - White - 50 pcs | String King Lacrosse LLC | 2021/4/23 |
| K202615 | Nordiwell Medical Face Mask | Changzhou Combat Protective Equipment Co. Ltd. | 2020/12/31 |
| K202627 | Medical Face Masks | Guilin HBM Sanitary Protections Inc | 2021/2/3 |
| K202628 | Disposable Medical Face Mask | Qinghai Zhong Dao Win-win Medical Protective Equipment Co. | 2021/3/19 |
| K202640 | Surgical Mask | Jiangsu Medpure Biological Technology Co. Ltd. | 2021/1/22 |
| K202647 | Surgical Mask | Ningbo Green Textile Co. Ltd. | 2021/4/26 |
| K202650 | Medical disposable face mask non sterile | Guangdong Zhong Ling Industrial Group Co. Ltd. | 2021/3/24 |
| K202655 | Disposable Medical Mask | Dongguan Runlin Medical Supplies Technology Co. LTD | 2021/4/5 |
| K202676 | Disposable Medical Face Mask | Zhejiang Senhong Medical&Instrument Co. Ltd. | 2021/11/5 |
| K202697 | United Sewing High Fluid Resistant Disposable Face Mask United Sewing High Fluid Resistant Surgical Mask United Sewing High Fluid Resistant Procedure Mask | United Sewing Automation Inc. | 2021/5/13 |
| K202708 | Surgical Face Masks | Intco Medical(HK) Co. Ltd. | 2021/3/30 |
| K202710 | Disposable Medical Face Mask | Wanxinda (Guangzhou) Technology Product Co. Ltd | 2021/3/9 |
| K202714 | Medical Face Mask | Chongqing Chaoke Industry Development Co. Ltd. | 2021/6/11 |
| K202719 | Disposable Medical Face Masks | Jiangxi Sanxin Medtec Co. Ltd. | 2021/1/4 |
| K202745 | Disposable medical face mask | Ningbo Jingeao Electronics Inc. | 2021/8/23 |
| K202746 | Surgical mask | Ningbo Jingeao Electronics Inc. | 2021/8/27 |
| K202759 | Disposable medical surgical mask | Chongqing COE Display Technology Co. Ltd. | 2021/4/21 |
| K202761 | Medical Surgical Mask (Non-sterile) | Guangdong GoodFeeling Hygiene Material Tec Co. Ltd. | 2021/4/11 |
| K202794 | Surgical face mask: F-Y1-A | Jiande Chaomei Daily Chemicals Co. Ltd | 2021/12/13 |
| K202824 | BRS Procedure Face Mask | Blackbriar Regulatory Services LLC | 2021/3/25 |
| K202842 | Medical surgical mask | Henan Huibo Medical Co.Ltd. | 2021/11/26 |
| K202843 | Surgical Face Masks (Sterile) Surgical Face Masks (Non-sterile) | B.J.ZH.F.Panther Medical Equipment Co. Ltd | 2021/1/12 |
| K202899 | Procedure Mask Surgical Mask | Kenpax International Limited | 2021/5/20 |
| K202903 | Surgical Face Mask | Rizhao Sanqi Medical & Health Articles Co. Ltd. | 2022/3/24 |
| K202904 | Surgical Face Mask | Jiangxi Feilikang Medical Technology Co. Ltd. | 2021/1/21 |
| K202905 | Disposable Face Mask | Jiangsu Excellence Medical Supplies Co. Ltd | 2021/3/26 |
| K202954 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co. Ltd | 2021/7/2 |
| K203012 | Surgical Mask | Customfab INC. | 2021/4/11 |
| K203064 | ICU Health Surgical Mask | Plastikon Industries | 2021/3/23 |
| K203101 | Secure Wear USA Surgical Face Mask | Secured Ortho Manufacturing of America LLC | 2021/3/31 |
| K203112 | Disposable Medical Mask | Yangzhou Runyi Arts & Crafts CO. LTD. | 2021/9/16 |
| K203152 | Disposable Face Mask | Chaozhou Cecilia Technology Co. Ltd. | 2021/8/11 |
| K203161 | Surgical Face Mask | Wuhan Raytex Protection CO. LTD | 2022/1/20 |
| K203174 | Disposable Medical Mask | Dong Guan Kinyet Metal Products Co. Ltd | 2021/8/2 |
| K203190 | Surgical Face Mask | RFX+CARE Manufactoring Co. Ltd. | 2021/6/2 |
| K203200 | Disposable Medical Surgical Face Mask | Guangdong Haiou Medical Apparatus Co. Ltd. | 2021/6/16 |
| K203265 | nPro Surgical Mask | NP Medical Inc | 2021/2/9 |
| K203376 | ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask Model number: FM-1400G | Medtecs (Taiwan) Corp. | 2022/3/2 |
| K203388 | Disposable medical mask | Everwin Toys (Dongguan). Ltd. | 2021/6/4 |
| K203418 | Surgical Mask (Procedure Mask) (Models: OH02-01 OH02-01 (Bandage)) | Ningbo Ouhan Medical Device Co. Ltd. | 2021/9/17 |
| K203425 | Surgical Mask | BDC Dental Corporation Ltd. | 2021/3/5 |
| K203426 | Surgical Face Mask (non-sterile) | Nantong Taiweishi Medical Technology Co. Ltd. | 2021/2/18 |
| K203455 | Disposable Medical Mask | Fujian Kang Chen Daily Necessities CO. LTD | 2021/9/13 |
| K203524 | Surgical Masks | Bain Medical Equipment (Guangzhou) Co. Ltd. | 2021/2/25 |
| K203534 | Surgical face mask (Model: Flat Ear Loop/CN102) | Crown Name Disposable Hygiene Products Fty. Ltd. | 2021/7/21 |
| K203565 | Surgical 3D Mask | Inno Lifecare | 2021/10/19 |
| K203591 | Single-use Medical Face Mask | Conod Medical Co. Limited | 2021/7/2 |
| K203646 | Disposable Medical Face Mask | Guangzhou Mei Yi Kang Medical Technology CO. LTD. | 2021/4/22 |
| K203685 | Disposable Surgical Face Mask | Xiantao Zhongyi Safety & Protection Products Co. Ltd | 2021/3/26 |
| K203704 | Surgical face mask | Juntech(Jiaxing)Healthcare Materials Co.Ltd | 2021/6/4 |
| K203732 | Surgical Face Mask | Zhuhai Gaoge Medical Technology Co. Ltd. | 2021/6/11 |
| K203756 | Disposable Surgical Mask | Lucky Textile Industrial(Wuxi) Co.Ltd. | 2021/6/10 |
| K203775 | AIC disposable medical mask | The Aleen International Corporation | 2021/3/12 |
| K203776 | Surgical Masks Model SNN200640 & MN112 | SQ Medical Supplies Inc. | 2021/3/25 |
| K203801 | Disposable Surgical Face Mask | Anhui Jiabao Protective Equipments Co. Ltd | 2021/4/6 |
| K210007 | Face Mask | Jinhua Jingdi Medical Supplies Co. Ltd | 2021/4/23 |
| K210015 | Surgical Face Mask | Sample King Manufacturing Ltd | 2021/6/10 |
| K210018 | Disposable Medical Mask | Diasia Biomedical Technology Co. Ltd. | 2021/4/11 |
| K210020 | Medical Mask | Zhende Medical Co. Ltd. | 2021/4/28 |
| K210023 | Surgical Face Mask | Guangdong Winsun Personal Care Products Co.Ltd | 2021/4/2 |
| K210030 | Medical Surgical Mask | Tianjin Aoshang Outdoor Equipment Co. Ltd. | 2021/4/23 |
| K210042 | Disposable Surgical Mask | Suzhou Letian Protective Products Co. Ltd. | 2021/11/17 |
| K210063 | Freudenberg Surgical Mask | Freudenberg Performance Materials LP | 2021/2/5 |
| K210101 | American-Made Surgical Mask | Armbrust Inc. | 2022/1/26 |
| K210102 | Topwide Surgical Face Mask | Topwide (Hubei) Medical Products Manufacturer | 2021/12/17 |
| K210147 | Unico High Performance Surgical Mask Unico High Performance Surgical Mask with Face Shield | Unicoglobal Inc. | 2021/12/22 |
| K210150 | Disposable Medical mask | Hubei Wanli Protective Products Co. Ltd. | 2021/6/2 |
| K210181 | Nordiwell Surgical Face Mask | Changzhou Combat Protective Equipment Co. Ltd. | 2021/3/9 |
| K210184 | Wilson Tech Disposable Medical Face Mask | Wilson Tech (International) Limited | 2021/9/14 |
| K210218 | SURGICAL MASK Model Name:C015 | Qingdao Hainuo Biological Engineering Co. Ltd. | 2021/5/7 |
| K210222 | Disposable Medical Mask | Guangdong Lide Medical Technology Co. Ltd. | 2021/11/2 |
| K210225 | Surgical Face Mask | Feng Chun Yuan Medical Equipment (Shenzhen) Co. Ltd | 2021/3/4 |
| K210244 | Disposable Medical Face Mask | Suzhou Bolisi Medical Technology Co. Ltd | 2021/7/12 |
| K210256 | CiRx (R) Surgical Mask | Ningbo Shun Ye Medical Company Ltd. | 2021/8/19 |
| K210267 | Disposable Surgical Mask | Xiamen Eagledon Pharmaceutical Co. Ltd | 2021/7/8 |
| K210302 | Disposable Medical mask | Anhui JBH Medical Apparatus Co. Ltd. | 2021/5/14 |
| K210304 | Surgical Mask | Jin Pin Electrical CO. LTD. Zhuhai S.E.Z. | 2021/5/4 |
| K210348 | Disposable Medical Surgical Mask | Weihai Dishang Medical Technology Co. Ltd | 2021/10/24 |
| K210372 | Disposable Surgical Mask | Dongguan Shin Yi Healthcare Products Factory | 2021/6/7 |
| K210380 | Medical surgical mask | Shantou T&K Medical Equipment Factory Co.Ltd | 2021/7/8 |
| K210391 | Single-use medical face mask | Zhuhai Herald Datanetics Limited. | 2021/7/22 |
| K210409 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co. Ltd | 2021/7/28 |
| K210422 | INTAI Surgical Mask (non-sterile) | INTAI Technology Corp. | 2022/3/30 |
| K210429 | Disposable Surgical Face Mask | Jiangxi Heying Pharmaceutical Co. Ltd | 2021/6/2 |
| K210433 | Surgical Face Mask (Ear loops and Tie-on) | Wuhan Dymex Healthcare Co. Ltd. | 2021/6/7 |
| K210445 | Nordiwell Surprotect Face Mask | Changzhou Combat Protective Equipment Co. Ltd. | 2021/6/29 |
| K210487 | MIPLNI YK-244 Disposable Surgical Mask | Hunan Yuankang Biological Technology Co. Ltd | 2021/3/16 |
| K210513 | UNIWEB Surgical Mask Model: ASTM Level 1 UNIWEB Surgical Mask Model: ASTM Level 2 | Universal Incorporation | 2021/9/29 |
| K210518 | Surgical Face Mask | Shandong Haidike Medical Products Co. Ltd. | 2021/6/14 |
| K210524 | Surgical Mask | Changzhou Holymed Products Co. Ltd. | 2021/7/7 |
| K210622 | Single-Use Medical Face Mask | Jiangxi Hongda Medical Equipment Group Co. Ltd. | 2021/10/8 |
| K210641 | Disposable Medical Mask | Tuosheng Protective Products (Ningbo) Co. Ltd | 2021/6/7 |
| K210643 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co. Ltd | 2021/8/4 |
| K210679 | Medical Face Mask | Wuxi Yushou Medical Appliances Co.Ltd. | 2022/1/18 |
| K210698 | ECOMA Level 2 Disposable Surgical Mask with Ear Loops | Xianning Eco Medical Articles Co. Ltd. | 2021/8/19 |
| K210705 | Defender Safety Procedure Mask Level 1 Defender Safety Procedure Mask Level 3 Defender Safety Surgical Mask Level 3 | Defender Safety Inc. | 2021/5/6 |
| K210744 | Surgical Mask | Chongqing Pa Xijia Biotechnology Co. Ltd. | 2021/12/14 |
| K210761 | Velguard Surgical Face Mask | Esstee Exports Health Care Division | 2021/7/16 |
| K210767 | Surgical Masks Model:FE-1 | Hunan Triplex Precision Medical Devices Co. Ltd | 2021/6/10 |
| K210772 | 3-Layer Medical Face Masks (XMM3L3C) 3-Layer Medical Face Masks with ties (XMM3HT) | VR Vertical LLC dba XRGO | 2021/9/22 |
| K210813 | Medical Surgical Mask | Sichuan Pharmaceutical. Inc. | 2021/10/8 |
| K210815 | Disposable Face Mask | Biobase Scientific (Shandong) Co. Ltd. | 2021/5/13 |
| K210840 | Disposable Surgical Mask | Safeway Industry Healthcare. | 2021/6/22 |
| K210845 | Disposable Surgical Mask (Model: YYKZ-01) | Jiaxing Amazing Travel-Ware CO.LTD | 2021/10/12 |
| K210856 | Purism Disposable Surgical Mask | Chuzhou Daddy's Choice Science and Technology Co. Ltd. | 2021/7/28 |
| K210860 | Comfort Guard Mask level 1 Comfort Guard Mask level 3 | GRI-Alleset Inc | 2022/4/7 |
| K210870 | MEO Med Disposable Medical Face Mask | Fujian MEO Medical Technology Limited | 2021/7/30 |
| K210878 | Surgical Face Mask (Model: CM2006 CM2008 A88) | Shenzhen RealTone Medical Appliance Co. Ltd. | 2021/9/28 |
| K210908 | Surgical Mask | Sichuan Prius Biotechnology Co. Ltd. | 2021/9/26 |
| K210970 | Single-Use Surgical Mask Model FE2311B | BYD Precison Manufacturer Co. Ltd. | 2021/7/21 |
| K211042 | Disposable Procedural Ear-loop Face Mask | Changzhou DSB Medical Co. LTD | 2021/7/15 |
| K211062 | Medical Face Mask | Ammex-Weida (Hubei) Health and Safety Products Co. Ltd | 2021/6/8 |
| K211066 | Sovereign America Surgical Mask Model Number: 2000SM2 Sovereign America Surgical Mask Model Number: 2000SM3 | Homtex Inc. | 2021/8/19 |
| K211097 | Banyan USA Surgical Mask Level 3 | Banyan USA LLC | 2021/9/22 |
| K211105 | Ear-Friendly Mask | Ray Co. Ltd. | 2021/5/17 |
| K211165 | Medical Face Masks Model Name:MY020003 | Huizhou Jie Bai Purification Co.Ltd. | 2021/11/9 |
| K211249 | Altor Safety 3-Ply Surgical Mask (Model:62222) | Altor Safety LLC | 2021/7/23 |
| K211255 | Surgical Mask | Tianchang Kanghui Protective Products CO LTD | 2021/8/28 |
| K211260 | Sheng Jing Tang Surgical Mask | Liaoning Shengjingtang Biotechnology Co. Ltd. | 2022/1/10 |
| K211275 | AirMax Procedure Mask | PremiumEStore LLC | 2021/5/25 |
| K211295 | Surgical Mask (sterile) | Nanjing 3H Medical Products Co. Ltd. | 2021/11/24 |
| K211296 | Surgical face mask | Sunsmed Protective Products Ltd. | 2021/9/11 |
| K211353 | Medical Face Mask | Shenzhen Lyttop Healthcare Limited | 2021/8/11 |
| K211363 | Medical Face Mask | HuBei Kangning Protective Products Co. Ltd. | 2021/7/24 |
| K211378 | LM Surgical Mask Level 3 LM Surgical Mask Level 2 | Liberty Mask LLC | 2021/12/16 |
| K211425 | Private Stock Labs Surgical Face Mask | J.K. Private Stock Inc. | 2021/10/4 |
| K211440 | ASM-301 Level 3 Surgical Mask | American Surgical Mask Company LLC | 2021/6/2 |
| K211451 | Disposable Surgical Mask (non sterile) | Qinhuangdao Taizhi Medical Technology Co. Ltd. | 2021/8/25 |
| K211454 | Surgical mask | Jiangsu Xingtong Biotechnology Group Co. Ltd. | 2021/8/18 |
| K211462 | Disposable Ear-loop Medical Face Mask Disposable Tie-On Medical Face Mask | Xiantao S&J Protective Products Co. Ltd. | 2021/8/19 |
| K211487 | MAF Guard | MAF Clothing Pvt Ltd Unit-3 | 2021/12/8 |
| K211497 | Surgical Mask | Honeywell Safety Products | 2021/7/28 |
| K211520 | Amerishield Surgical Mask | PremiumEStore LLC | 2021/6/15 |
| K211536 | Welspun Health Surgical Mask | Welspun India Limited | 2021/9/1 |
| K211552 | Surgical mask | Shandong Shengquan New Materials Co. Ltd. | 2021/8/11 |
| K211576 | WYZ Surgical Mask | WYZ Medical Supplies LLC | 2021/8/19 |
| K211631 | Surgical Face Mask | Macheng Thimble Technology Investment Co. Ltd | 2021/8/18 |
| K211696 | Disposable Surgical Face Mask | Anhui Cleanpro Pharmpack Co. Ltd. | 2021/11/30 |
| K211750 | Disposable Surgical Face Mask Disposable Surgical Face Mask (Sterile) | National Bridge Industrial (S.Z.) Co. Ltd. | 2021/12/20 |
| K211751 | WELLTRUST WT-III Mask with Flat Earloop | Lonestar Meadows LLC | 2021/9/17 |
| K211762 | Altor Safety 4-Ply Surgical Mask (Model:62232) | Altor Safety LLC | 2021/9/3 |
| K211772 | PMW01 Procedure Mask Level 1 | Defender Safety Inc. | 2021/12/6 |
| K211773 | Single-use Surgical Mask | Taiwan Seafood and Fish Corporation | 2021/12/2 |
| K211794 | Disposable surgical mask | Shanghai No.9 Knitting Mill Co. Ltd. | 2021/9/28 |
| K211827 | Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F 1570F) | Zhejiang Lanhine Medical Products LTD | 2021/9/23 |
| K211832 | Fluid Resistant Procedure Mask Fluid Resistant Surgical Mask | Zhejiang Lanhine Medical Products LTD | 2021/9/8 |
| K211833 | Disposable Medical Face Mask | Zhejiang The Purples Protective Products Co.Ltd | 2022/1/16 |
| K211861 | TAIJI Professional Series Level 3 Surgical Face Mask | Taiji Medical Supplies Inc. | 2021/7/28 |
| K211897 | Surgical Face Mask | Zhejiang Hongyu Medicali Commodity CO. LTD | 2021/8/3 |
| K211899 | Surgical Face Mask | Hubei YI-YA PROTECTIVE PRODUCTS CO. LTD | 2021/10/4 |
| K211956 | 039 Surgical Face Mask | AOK Tooling Limited | 2021/11/23 |
| K211984 | MASC Surgical Mask | Mid-America Safety Corp. | 2021/7/25 |
| K212046 | Impertech Surgical Face Mask | Impertech Industries Ltd. | 2021/11/18 |
| K212059 | Surgical Face Mask | Zhongshan Saifute Labor Protective Articles CO. LTD | 2021/12/17 |
| K212097 | Disposable medical surgical mask | Hebei Titans Hongsen Medical Technology Co. LTD | 2021/8/18 |
| K212109 | Spin Care Disposable Protective Mask Level 3 | SpinTech LLC | 2021/11/14 |
| K212111 | Myflon Surgical Mask Level 3 | Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi | 2022/1/23 |
| K212120 | Surgical Masks | Hubei Xinxin Non-woven Co.Ltd. | 2022/1/28 |
| K212203 | Dong Hai Xiang Surgical Mask | Taizhou Donghaixiang Protective Equipment Co. Ltd | 2022/4/7 |
| K212205 | Medical Protective Masks | Qinhuangdao Taizhi Medical Technology Co. Ltd. | 2021/10/14 |
| K212235 | Surgical Face Mask | Shanghai Yunqing Industrial Co. Ltd. | 2021/12/6 |
| K212264 | Surgical Face mask | Nantong Taiweishi Medical Technology Co. Ltd. | 2021/11/13 |
| K212293 | Surgical Mask (Model: WK1701-02A WK1701-03A WK1701-04A) | Jiangmen Ningrui Medical Supplies Co. Ltd. | 2021/10/25 |
| K212299 | Medical Surgical Mask | Wepon Medical Technology Co. Ltd. | 2022/1/4 |
| K212302 | BAYLAB 3-Ply Surgical Mask (BEACON I) | Baylab USA LLC | 2021/12/7 |
| K212330 | Yadu Medical Face Mask (Level 1) | HeNan YADU Industrial Co. Ltd. | 2022/3/14 |
| K212344 | Surgical Mask | Xiantao Dingcheng Non-woven Product Co. Ltd | 2021/11/16 |
| K212366 | Heartland Health Surgical Mask | Heartland Health Products | 2022/2/19 |
| K212368 | Surgical Face Mask | Anhui Tiankang Medical Technology Co. Ltd. | 2021/10/24 |
| K212375 | Disposable Medical Surgical Mask | Jiangxi Bestgrand Health Technology Co. Ltd. | 2022/1/4 |
| K212398 | Surgical Face Mask (Non-sterile) | Hubei Kimsoul Industrial Co. Ltd | 2021/12/15 |
| K212451 | Surgical Mask | ReMade USA LLC | 2021/9/10 |
| K212460 | Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) | Guangzhou ZhengKang Medical Equipment Co.Ltd | 2021/11/5 |
| K212471 | Medical Face Mask | Haian Medigauze Co. Ltd | 2021/11/4 |
| K212526 | Surgical Face Mask | Suzhou JaneE Medical Technology Co. Ltd. | 2021/11/9 |
| K212574 | Surgical Face Mask | Xiantao Deming Healthcare products Co. Ltd | 2021/12/14 |
| K212575 | Surgical Face Mask | Hubei Huanfu Plastic Products Co. Ltd | 2021/11/14 |
| K212610 | Surgical Face Mask | Foshan Nanhai Plus Medical CO LTD | 2022/1/26 |
| K212726 | Disposable Medical Surgical Mask | Hubei Huaqiang High-Tech Co. Ltd. | 2022/3/23 |
| K212740 | Puravita Medical Fold Flat Surgical Mask | Puravita M LLC | 2021/12/2 |
| K212807 | Surgical Masks | Weihai Hongyu Nonwoven Fabric Products Co. Ltd. | 2021/12/3 |
| K212826 | Disposable Medical Mask | Jiangsu Nanfang Medical Co. Ltd. | 2022/1/19 |
| K212863 | Surgical Face Mask | Taiwan Comfort Champ Manufacturing Co. Ltd. | 2022/2/19 |
| K212867 | Medical Surgical Mask | Nanchang Kanghua Health Materials Co. Ltd | 2021/12/11 |
| K212913 | Surgical Face Mask | Jiangxi Ganlong Pharmaceutical Co.Ltd. | 2022/1/14 |
| K212944 | Disposable Surgical Mask | Heilongjiang Yinjia Medical Equipment Co. Ltd. | 2021/12/15 |
| K212994 | Medical Face Mask | Guangzhou Quantum Laser Intelligent Equipment Co. Ltd. | 2022/1/17 |
| K212997 | Surgical Mask | Guangdong Zhizhen Biological Medical Co. Ltd | 2022/1/14 |
| K213001 | Procedure Mask Surgical Mask | A Plus International Inc. | 2022/5/11 |
| K213136 | CPL Surgical Face Mask | Control Print Limited | 2021/12/24 |
| K213347 | ADI Medical Surgical Face Mask | Asia Dynamics Inc. d/b/a ADI Medical | 2022/1/25 |
| K213358 | Surgical Mask | Shenzhen SafeSecure Medical Infection Control Tech Co. Ltd | 2022/3/4 |
| K213406 | Savvy Mask - Level 3 Surgical Face Mask | Texas MedPlast LLC | 2021/11/18 |
| K213450 | Medical surgical mask (Black mask Level 1 and Level 3) | Guangdong Kingfa Sci.&Tech. Co. Ltd. | 2022/4/5 |
| K213617 | Surgical Face Mask | Megasoft (China) Co. Ltd. | 2022/2/11 |
| K213724 | Medical Surgical Mask | Hunan Zhenheyikang Medical Instrument Co. Ltd | 2022/2/20 |
| K213736 | Medical Face Mask | Hangzhou Runheng Medical Co. Ltd. | 2022/3/31 |
| K213806 | Disposable Medical Face Mask | Xiantao Zhibo Nonwoven Products Co. Ltd | 2022/3/12 |
| K213894 | DWFritz ASM2000 | DWFritz Automation Inc. | 2022/3/14 |
| K213920 | Kangbeier Surgical Mask (Model: KBR-1001) | Xinxiang Kangbeier Medical Technology Co. Ltd. | 2022/1/16 |
| K213970 | D-Care Surgical Face Mask 3 Ply D-Care Medical Face Mask 3 Ply | Danameco Medical Joint Stock Corporation | 2022/1/23 |
| K214085 | Disposable Medical Mask | Hubei Wanli Protective Products Co. Ltd | 2022/4/6 |
| K214087 | Medical Face Mask | Hubei Medlink Healthcare Co. Ltd | 2022/3/8 |
| K214094 | ROKI Surgical Mask | ROKI Co. Ltd. | 2022/2/24 |
| K220187 | Medical Surgical Mask (Model: JM92 JM92B) | Guangdong Jia Mei Biological technology Co.Ltd | 2022/3/25 |
| K220191 | Disposable Face Mask | Jiujiang Taixin Technology Co. Ltd. | 2022/5/24 |
| K220194 | Procedure mask/Surgical mask/Face mask | Winner Medical Co. Ltd. | 2022/5/17 |
| K220487 | Disposable Medical Face Mask | Hubei Mediunion Medical Products Co. Ltd. | 2022/4/26 |
| K220512 | Disposable Surgical Face Mask (M01 M02) | Fomed Industries Inc. | 2022/4/25 |
| K220532 | Disposable surgical mask | Xiamen Blue Star Enterprise Co. Ltd. | 2022/5/23 |
| K220597 | Disposable Surgical Face Mask (FM-34EEFM-44EE) | Qingdao Bestex Rubber & Plastic Products Co.Ltd. | 2022/5/26 |
| K220637 | 3 Ply Medical Grade Single Use Procedural Disposable Face Mask | KDI Med Supply | 2022/3/25 |
| K220749 | Surgical Face Mask Model Number-17.5X9.5CM EAR-LOOP | Unimax Medical Products Co. Ltd. | 2022/5/13 |
| K220824 | Medical Surgical Mask (Planar type) | Hunan Chopard Medical Devices Co. Ltd | 2022/5/19 |
| K221134 | Procedure Mask with Ear Loops and Surgical Mask with Ties | SafeSource Direct LLC | 2022/5/19 |
| K221222 | Surgical Face Mask (HNFM0304) | Shanghai Hua En Industrial CO LTD | 2022/6/6 |
| K831148 | HIGH FILTRATION ISO-MASK | TECNOL NEW JERSEY WOUND CARE INC. | 1984/7/17 |
| K832281 | TWO-PLY PAPER FACE FACE MASK | ABCO DEALERS INC. | 1983/8/12 |
| K850247 | PERITONEAL DIALYSIS COIL CATHETER | SIL-MED CORP. | 1985/2/14 |
| K851556 | OP-FACE MASK(MASQUE DE CHIRUGIE) | ROSEBURG SA | 1985/4/30 |
| K870056 | TECNOL CLASSIC CONE MASK | TECNOL NEW JERSEY WOUND CARE INC. | 1987/2/6 |
| K870312 | WHITE PLUME SURGICAL GAUZE FACE MASK | CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. | 1987/2/24 |
| K871558 | DENTAL FACE MASKS POLYESTER | CARL PARKER ASSOCIATES INC. | 1987/7/22 |
| K872935 | ANTI-INFECTION SHIELD | STACKHOUSE ASSOC. | 1987/11/9 |
| K873705 | CARERITE FACE MASK | COST RITE HEALTH PRODUCTS INC. | 1987/10/5 |
| K873731 | SAFETY SHIELD KIT | BALLARD MEDICAL PRODUCTS | 1988/1/15 |
| K873785 | TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE | TECNOL NEW JERSEY WOUND CARE INC. | 1987/11/2 |
| K874296 | INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER | ULTI-MED INTL. INC. | 1988/1/7 |
| K874608 | TECNOL FLUID SHIELD SURGICAL MASK | TECNOL NEW JERSEY WOUND CARE INC. | 1987/12/2 |
| K874894 | TECNOL LASER SURGICAL MASK | TECNOL NEW JERSEY WOUND CARE INC. | 1988/3/28 |
| K875008 | GUARDALL SHIELD | ANAGO INC. | 1988/3/11 |
| K875172 | DISPOSABLE SURGICAL FACE MASK | IREMA USA LTD. | 1988/1/22 |
| K875194 | KLEENSPEC DISPOSABLE FACE SHIELD MODEL 57001 | WELCH ALLYN INC. | 1988/1/22 |
| K880534 | ZEPHYR | RACAL HEALTH & SAFETY INC. | 1988/9/6 |
| K880613 | ACCO(R) FACE MASK | ABSORBENT COTTON CO. INC. | 1988/3/4 |
| K880757 | TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD | TECNOL NEW JERSEY WOUND CARE INC. | 1988/3/11 |
| K881372 | ENDICOTT & BEAMAN SUPRA-TEC FACE MASK | ENDICOTT & BEAMAN INC. | 1988/4/8 |
| K881618 | ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK | 3M COMPANY | 1988/5/9 |
| K881910 | LABELING CHANGE TO SURGICAL FACE MASK | LOUIS M. GERSON CO. INC. | 1988/5/18 |
| K881913 | PROTECTO-SHIELD | SYNTECH MFG. SERVICES | 1988/7/8 |
| K882026 | ADD-A-SHIELD | BFD INC. | 1988/6/15 |
| K882027 | COMBO-SHIELD | BFD INC. | 1988/6/15 |
| K882028 | COVERALL SHIELD | BFD INC. | 1988/6/15 |
| K882882 | C-MASK | PROMEDICA PRODUCTS INC. | 1988/8/10 |
| K882883 | C-MASK(FLAT) | PROMEDICA PRODUCTS INC. | 1988/8/10 |
| K883658 | I-SPOSE EYE SHIELD | PRODUCTS FOR MEDICINE | 1988/10/25 |
| K883705 | FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS | SELECT SOURCES INC. | 1988/11/14 |
| K883827 | MASKS VARIOUS TYPES OF SURGICAL MASKS | GREENE INTERNATIONAL CORP. | 1988/11/17 |
| K883828 | CONE MASKS VARIOUS TYPES OF SURGICAL CONE MASKS | GREENE INTERNATIONAL CORP. | 1988/10/3 |
| K884392 | KBM DENTAL MASK | KAWAMOTO BANDAGE MATERIAL CO. LTD. | 1988/11/18 |
| K884877 | OCUSHIELDS MASKS | DIOPTICS | 1989/1/10 |
| K884929 | OCCUSHIELDS | DIOPTICS | 1988/12/15 |
| K890016 | FACE MASK | ANJUDD INTL. | 1989/2/3 |
| K890128 | FACELOCK FILTER MASK | ALPHA PRO TECH INC. | 1989/2/14 |
| K890771 | ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK | 3M COMPANY | 1989/3/14 |
| K891051 | SURGICAL FACE MASK-EAR LOOP | DISPOMED INC. | 1989/4/12 |
| K891052 | SPLASH GUARD GOGGLE | DISPOMED INC. | 1989/4/12 |
| K891056 | SURGICAL CONE MASK | DISPOMED INC. | 1989/4/12 |
| K891141 | CARERITE FACE MASK | COST RITE HEALTH PRODUCTS INC. | 1989/4/18 |
| K891409 | PRECEPT MICRO-GARD LASER MASK | MARS WHITE KNIGHT | 1989/4/7 |
| K892451 | SAFE-T-FACE DISPOSABLE FACE SHIELD | BARRY S. SMITH CO. | 1989/5/15 |
| K893417 | SURGIFRESH SUB-MICRON MASK NO. 901008-000 | TEXAS MEDICAL PRODUCTS INC. | 1989/6/22 |
| K893634 | MODIFIED STERILIZATION OF TUR APRONS | BRANT-WALD SURGICALS INC. | 1989/6/23 |
| K893939 | ISOLATION MASKS | JAMES RIVER CORP. | 1989/7/14 |
| K894516 | VISOSHIELD(TM) SURGICAL EYE PROTECTOR | POLAMEDCO INC. | 1989/9/12 |
| K894905 | FACE PROTECTION PAK(TM) | PROTECH PRODUCTS | 1989/9/12 |
| K895077 | SURGICAL MASK/DENTAL MASK | ASHTON MEDICAL PRODUCTS INC. | 1989/11/3 |
| K896193 | TECNOL LAZER(TM) SURGICAL MASK | TECNOL NEW JERSEY WOUND CARE INC. | 1990/2/27 |
| K900088 | MASKS SURGICAL DENTAL | KAB GLOVES UNLTD. | 1990/3/8 |
| K900665 | DRESSING CHANGE KIT | HEALTHDYNE CARDIOVASCULAR INC. | 1990/5/14 |
| K902546 | THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK | ANAGO INC. | 1990/9/5 |
| K902547 | THE PROTECTOR II LASER SURGICAL MASK | ANAGO INC. | 1990/9/5 |
| K903486 | MASK SURGICAL-DISPOSABLE NSN 6510-00-982-7493 | PENNSYLVANIA ASSOCIATION FOR THE BLIND | 1990/10/23 |
| K905209 | SURGICAL MASK | LANCASTER COUNTY BLIND ASSOC. | 1991/2/21 |
| K905749 | SURGICAL FACE MASK | ANAGO INC. | 1991/3/4 |
| K905865 | ANTI-FOR SURGICAL FACE MASK | ANAGO INC. | 1991/3/6 |
| K910110 | TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK | 3M COMPANY | 1991/3/20 |
| K910182 | 3M BRAND EAR LOOP FACE MASK 2000F | 3M COMPANY | 1991/3/4 |
| K910557 | BARRIER* EXTRA PROTECTION PLUS FACE MASK | JOHNSON & JOHNSON MEDICAL INC. | 1991/4/29 |
| K911334 | MASK SURGICAL APPAREL | THAI HOSPITAL PRODUCTS CO. LTD. | 1991/8/29 |
| K911891 | FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK | TECNOL NEW JERSEY WOUND CARE INC. | 1991/7/12 |
| K911907 | FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS | TECNOL NEW JERSEY WOUND CARE INC. | 1991/7/8 |
| K913043 | MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS | TECNOL NEW JERSEY WOUND CARE INC. | 1991/8/23 |
| K913558 | RELIABLE CONE STYLE FACE MASK | ANAGO INC. | 1991/11/7 |
| K914412 | MASK SURGICAL DISPOSABLE | INDUSTRIES FOR THE BLIND | 1991/12/19 |
| K914832 | SURGICAL APPAREL | W.L. GORE & ASSOCIATESINC | 1992/2/14 |
| K915817 | TECNOL FLUIDSHIELD INFECTION CONTROL MASK | TECNOL MEDICAL PRODUCTS INC. | 1993/1/27 |
| K920108 | BARRIER EXTRA PROTECTION PLUS FACE MASK | JOHNSON & JOHNSON MEDICAL INC. | 1994/2/10 |
| K920162 | TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK | TECNOL MEDICAL PRODUCTS INC. | 1993/1/27 |
| K920203 | TECNOL INFECTION CONTROL MASK | TECNOL MEDICAL PRODUCTS INC. | 1992/10/5 |
| K920682 | PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001 | PHOENIX STERI-TECH INC. | 1992/4/28 |
| K920846 | CENTRAL VENOUS CATHETER DRESSING CHANGE KIT STER | TRINITY LABORATORIES INC. | 1992/9/1 |
| K922507 | GERSON ISOLAIR APR PARTICULATE SURGICAL MASK | LOUIS M. GERSON CO. INC. | 1992/11/16 |
| K922716 | SPLASH SHIELD # 4505 4507 PARASHIELD # 4509 | SPLASH SHIELD INC. | 1992/10/23 |
| K925185 | ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS | LOUIS M. GERSON CO. INC. | 1994/2/3 |
| K925290 | CATALOG NUMBER 111 (FACESHIELD) | ANSLEY MEDICAL PRODUCTS INC. | 1993/7/23 |
| K930067 | BUFFALO FILTER SURGICAL MASK | BUFFALO FILTER CO. INC. | 1993/11/30 |
| K931580 | DISPOSABLE SURGICAL MASK (MODIFIED) | BAM CORP. LTD. | 1994/5/2 |
| K932132 | EYSOTEK | ISOTECH CORP. | 1994/4/29 |
| K932133 | EYSOTEK | ISOTECH CORP. | 1994/4/29 |
| K932137 | FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR | TECNOL MEDICAL PRODUCTS INC. | 1994/4/15 |
| K932834 | TECNOL PCM 2000 | TECNOL MEDICAL PRODUCTS INC. | 1994/5/3 |
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| K942470 | PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315 | PROTECTAIDE INC. | 1994/10/18 |
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| K946343 | INTEC EXTENDED EYE SHIELD WITH MASK | INTEC INDUSTRIES INC. | 1995/3/22 |
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| K951913 | OVAL SURGICAL FACE MASK | OVAL INDUSTRIES LTD. | 1995/10/12 |
| K952961 | BODY FLUID BARRIER KIT | LHB INDUSTRIES INC. | 1996/1/23 |
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| K953102 | BLOODBORNE PATHOGEN KIT | CERTIFIED SAFETY MFG. INC. | 1995/12/11 |
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| K955556 | FLUID RESISTANT MASK | AMERICAN THRESHOLD HEALTHCARE | 1996/4/25 |
| K955557 | FLUID REISISTANT EYESHIELD MASK | AMERICAN THRESHOLD HEALTHCARE | 1996/4/25 |
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| K961217 | BODILY FLUID DISPOSAL KIT | TRANSIDYNE GENERAL CORP. | 1996/7/25 |
| K961402 | STS SHIELD WITH MASK | INNOVATIVE OUTSOURCING SOLUTIONS | 1996/7/12 |
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| K962443 | N95 FILTERING FACEPIECE | SURVIVAIR INC. | 1997/1/3 |
| K962654 | COMPLEAT SURGICAL MASK | CARL PARKER ASSOCIATES INC. | 1997/1/27 |
| K963568 | MASK SURGICAL | THE INNOVATIVE APPROACH CORP. | 1997/2/25 |
| K964114 | DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS | DEPUY INC. | 1997/5/6 |
| K964168 | PROCEDURE SPECIFIC KITS | SAGE PRODUCTS INC. | 1997/3/3 |
| K964358 | AMSEAL SURGICAL FACE MASK | AMERICAN SEAL CO. | 1997/2/14 |
| K964722 | DELTA N95 RESPIRATOR | RACAL FILTER TECHNOLOGIES INC. | 1997/2/7 |
| K964723 | RACAL N95 RESIRATOR | RACAL FILTER TECHNOLOGIES INC. | 1997/2/7 |
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| K965107 | MEDLINE ADMISSION KITS | MEDLINE INDUSTRIES INC. | 1997/3/11 |
| K970440 | EKONIC DENTAL/MEDICAL MASK (MD 610) | EKONIC COMPANY LTD. | 1997/3/27 |
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| K984389 | TOP WHOLESOME FACE MASK | TOP WHOLESOME ENTERPRISE CO. LTD. | 1999/4/9 |
| K990719 | EARLOOP FACE MASK | SHUENN BAO SHING CORP. | 1999/7/12 |
| K991559 | MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD | MEDLINE INDUSTRIES INC. | 1999/8/23 |
| K992604 | HENRY SCHEIN SURGICAL MASK | MITSUI TEXTILE CORP. | 2000/1/28 |
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