FXX
607 FDA 510(k) clearances · Product code
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| Record | Firm | Date |
|---|---|---|
| Surgical Masks, Model SNN200640 & MN112 (K203776) | Sq Medical Supplies, Inc. | 2021-03-25 |
| Disposable Medical Mask (K202133) | Hangzhou Qianzhiya Sanitary Products Co., Ltd. | 2021-03-25 |
| BRS Procedure Face Mask (K202824) | Blackbriar Regulatory Services, LLC | 2021-03-25 |
| Medical disposable face mask non sterile (K202650) | Guangdong Zhong Ling Industrial Group Co., Ltd. | 2021-03-24 |
| ICU Health Surgical Mask (K203064) | Plastikon Industries | 2021-03-23 |
| Disposable Medical Face Mask (K202628) | Qinghai Zhong Dao Win-Win Medical Protective Equipment Co., | 2021-03-19 |
| Sovereign America Surgical Face Mask (K201095) | Homtex, Inc. | 2021-03-19 |
| Spin Care Disposable Protective Mask (K201624) | Spintech, LLC | 2021-03-18 |
| MIPLNI YK-244 Disposable Surgical Mask (K210487) | Hunan Yuankang Biological Technology Co., Ltd. | 2021-03-16 |
| Single-Use Surgical Mask (K201924) | Qiqihar Hengxin Medical Supplies, Ltd. | 2021-03-15 |
| Medical Surgical Mask (K201698) | Hangzhou Mycode Bio-Medicine Co., Ltd. | 2021-03-15 |
| AIC disposable medical mask (K203775) | The Aleen International Corporation | 2021-03-12 |
| Surgical Face Mask (K202548) | Wanxinda (Guangzhou) Technology Product Co., Ltd. | 2021-03-10 |
| Surgical Face Mask (K202161) | Hunan Eexi Technology & Service Co., Ltd. | 2021-03-10 |
| Surgical Mask (K202411) | Allmed Medical Products Co., Ltd. | 2021-03-10 |
| Surgical Face Mask (K202205) | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-03-09 |
| Surgical Mask (K202409) | Allmed Medical Products Co., Ltd. | 2021-03-09 |
| Nordiwell Surgical Face Mask (K210181) | Changzhou Combat Protective Equipment Co., Ltd. | 2021-03-09 |
| Disposable Medical Face Mask (K202710) | Wanxinda (Guangzhou) Technology Product Co., Ltd. | 2021-03-09 |
| Disposable Medical Face Mask (K202439) | Hunan Eexi Technology & Service Co., Ltd. | 2021-03-08 |
| Single-use medical face mask (K201974) | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2021-03-07 |
| Surgical Mask (K203425) | Bdc Dental Corporation , Ltd. | 2021-03-05 |
| Disposable medical mask (K202137) | U-Play Products Corporation | 2021-03-04 |
| Surgical Face Mask (K210225) | Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. | 2021-03-04 |
| Medical mask (Model: KKF-1A) (K202316) | Han Zhaoqing Sporting Goods Company Limited | 2021-03-03 |
| Surgical Mask-Model Number: Ear Loop, Flat-Pleated (K201852) | Huizhou Foryou Medical Devices Co., Ltd. | 2021-03-02 |
| IFM Surgical Mask Model SM3 (K202214) | Fssc, LLC | 2021-03-02 |
| Disposable Surgical Mask/Fluid Resistant Procedure Mask (K202240) | Lhm Medical Technology (Hong Kong) Limited | 2021-02-25 |
| Surgical Masks (K203524) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-02-25 |
| Phyziofit Medical Surgical Mask (K201868) | Wellpower Sporting Goods Co., Ltd. | 2021-02-22 |
| iMask Disposable Surgical Face Mask (K201182) | Pac-Dent, Inc. | 2021-02-19 |
| Surgical Face Mask (non-sterile) (K203426) | Nantong Taiweishi Medical Technology Co., Ltd. | 2021-02-18 |
| Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On (K201732) | Dukal Corporation | 2021-02-16 |
| Disposable Surgical Mask (K202341) | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2021-02-12 |
| Surgical Face Mask (K201545) | Amphastar Nanjing Pharmaceuticals, Inc. | 2021-02-12 |
| Standard Procedure Mask, Standard Surgical Mask (K202605) | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | 2021-02-10 |
| nPro Surgical Mask (K203265) | Np Medical, Inc. | 2021-02-09 |
| Freudenberg Surgical Mask (K210063) | Freudenberg Performance Materials LP | 2021-02-05 |
| 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 (K201421) | Dukal Corporation | 2021-02-05 |
| Medical Face Mask (K202493) | Gemtier Medical (Shanghai), Inc. | 2021-02-04 |
| Medical Face Masks (K202627) | Guilin Hbm Sanitary Protections, Inc. | 2021-02-03 |
| 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On (K202096) | Ecoguard, Inc. | 2021-02-02 |
| Medical Face Mask (K202331) | Gemtier Medical (Shanghai), Inc. | 2021-02-02 |
| Disposable Medical Surgical Mask (K202511) | Improve Medical (Hunan) Co., Ltd. | 2021-02-02 |
| Disposable Medical Surgical Masks (K202323) | Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd. | 2021-02-02 |
| Protective Face Mask for Medical Use (K202358) | Hunan Heng Chang Pharmaceutical Co., Ltd. | 2021-01-29 |
| Surgical Mask (K202640) | Jiangsu Medpure Biological Technology Co., Ltd. | 2021-01-22 |
| Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask (K202595) | Premier Guard USA, LLC | 2021-01-21 |
| Surgical Face Mask (K202904) | Jiangxi Feilikang Medical Technology Co., Ltd. | 2021-01-21 |
| Medical Protective Mask (K202107) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021-01-15 |
| Procedure face mask (Model: KKF-2A) (K202314) | Han Zhaoqing Sporting Goods Company Limited | 2021-01-13 |
| Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) (K202843) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2021-01-12 |
| Disposable Medical Surgical Mask (K201625) | Tianjin Saiyuan Technology Co., Ltd. | 2021-01-12 |
| Medical Surgical Mask-Model MP002-5, MP002-6 (K202577) | Jiangmen Sure&Me Medical Product Co., Ltd. | 2021-01-11 |
| Disposable Surgical Face Mask (K202491) | Jiangsu Newvalue Medical Products Co., Ltd. | 2021-01-06 |
| Medical Surgical Masks-Non Sterile (K202594) | Shandong T&F Nonwoven Co., Ltd. | 2021-01-06 |
| Disposable Medical Face Masks (K202719) | Jiangxi Sanxin Medtec Co., Ltd. | 2021-01-04 |
| Nordiwell Medical Face Mask (K202615) | Changzhou Combat Protective Equipment Co., Ltd. | 2020-12-31 |
| JianYu Surgical Mask (K201754) | Jiangsu Jianyu Health Medical Co., Ltd. | 2020-12-30 |
| Medical Face mask (K202061) | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | 2020-12-23 |
| Disposable Medical Surgical Face Masks (K202211) | Guangdong Kaidi Garments Co.,Ltd | 2020-12-22 |
| Medical Surgical Mask (K202029) | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020-12-16 |
| Medical Face Mask (K201629) | Shandong Shengquan New Material Co., Ltd. | 2020-12-14 |
| Disposable Surgical Mask (K201893) | Xiamen Probtain Medical Techology Co., Ltd. | 2020-12-09 |
| Medical Mask (K201729) | Zhende Medical Co., Ltd. | 2020-12-03 |
| BASE4 Disposable Medical Mask (K202069) | Base4 Group, Inc. | 2020-12-01 |
| Medical surgical mask (K201622) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020-11-24 |
| Medical surgical mask (K201991) | Shenzhen Everwin Precision Technology Co., Ltd. | 2020-11-23 |
| Medical surgical mask (K202139) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020-11-20 |
| Livocare Surgical Mask (K201380) | Andon Health Co, Ltd. | 2020-10-07 |
| Surgical Face Mask (K202277) | Jiangxi 3l Medical Products Group Co., Ltd. | 2020-09-25 |
| Disposable Surgical Mask (K202463) | Unisources Group, LLC | 2020-09-18 |
| Single-Use Surgical Mask With Ear Loop (K201691) | Qiqihar Hengxin Medical Supplies, Ltd. | 2020-09-17 |
| Surgical Mask-Model Number CW01 (K202354) | Hunan Heng Chang Pharmaceutical Co., Ltd. | 2020-09-08 |
| Disposable Medical Face Mask (K201470) | Jkh USA, LLC | 2020-09-08 |
| Protective Face Mask for Medical Use (K201537) | Shandong Shengquan New Material Co., Ltd. | 2020-09-04 |
| Plain Surgical Mask (K201517) | Aok Tooling Limited | 2020-09-04 |
| Motex Anti-Fog Surgical Face Mask (K201549) | Modern Healthcare Corp. | 2020-08-26 |
| Single-use Surgical Mask (K200923) | Byd Precision Manufacturer Co., Ltd. | 2020-08-26 |
| Asept Surgical Face Mask (K201137) | Pfm Medical, Inc. | 2020-08-19 |
| Surgical Mask (K201871) | C & S Paper Yunfu Co., Ltd. | 2020-08-12 |
| DemeMASK (K201479) | Demetech Corporation | 2020-07-24 |
| Surgical Face Mask (K200847) | Mexpo International, Inc. | 2020-04-23 |
| ClearMask Transparent Surgical Face Mask (K200576) | Clearmask, LLC | 2020-04-06 |
| Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (K192374) | Cardinal Health200, LLC | 2019-12-02 |
| 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask (K191355) | 3M Healthcare | 2019-09-11 |
| Surgical Face Mask (K182515) | Wuhan Dymex Healthcare Co., Ltd. | 2019-05-27 |
| Surgical Face Mask (K182514) | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2019-01-24 |
| 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield (K180874) | 3M Healthcare | 2018-07-31 |
| Technoweb Surgical Mask (K172500) | Yts Global, Inc. | 2018-03-01 |
| Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) (K173062) | V&Q Manufacturing Corporation | 2018-01-25 |
| Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield (K171162) | Prestige Ameritech | 2017-08-15 |
| Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) (K153409) | Protect U Guard, LLC | 2016-11-15 |
| Surgical Face Masks (Ear loops and Tie-on) (K160269) | San-M Package Co., Ltd. | 2016-09-06 |
| Skypro, SP01 Mask (K152197) | Skypro Medical Supplies Company | 2016-08-26 |
| Disposable Surgical Face Mask (K153496) | Xiantao Rayxin Medical Products Co., Ltd. | 2016-06-15 |
| Communicator Surgical Facemask with Clear Window (K152561) | Prestige Ameritech , Ltd. | 2016-06-03 |
| SURGICAL FACE MASK (Ear Loops and Tie-on) (K133070) | Bh Medical Products Co., Ltd. | 2015-06-22 |
| Pasture 60S Surgical Mask (K141875) | Pasture Pharma Pte, Ltd. | 2015-05-05 |
| WestTec Procedure Facemask;WestTec Surgical Facemask (K141085) | Westtec, LLC | 2015-03-27 |
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