FDA Product Code
FDA Product Code FXX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4040
510(k) Clearances — 607 records · page 4 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202133 | Disposable Medical Mask | Hangzhou Qianzhiya Sanitary Products Co., Ltd. | 2021-03-25 | Traditional | PDF ↗ |
| K203776 | Surgical Masks, Model SNN200640 & MN112 | Sq Medical Supplies, Inc. | 2021-03-25 | Traditional | PDF ↗ |
| K202824 | BRS Procedure Face Mask | Blackbriar Regulatory Services, LLC | 2021-03-25 | Abbreviated | PDF ↗ |
| K202650 | Medical disposable face mask non sterile | Guangdong Zhong Ling Industrial Group Co., Ltd. | 2021-03-24 | Traditional | PDF ↗ |
| K203064 | ICU Health Surgical Mask | Plastikon Industries | 2021-03-23 | Abbreviated | PDF ↗ |
| K201095 | Sovereign America Surgical Face Mask | Homtex, Inc. | 2021-03-19 | Abbreviated | PDF ↗ |
| K202628 | Disposable Medical Face Mask | Qinghai Zhong Dao Win-Win Medical Protective Equipment Co., | 2021-03-19 | Traditional | PDF ↗ |
| K201624 | Spin Care Disposable Protective Mask | Spintech, LLC | 2021-03-18 | Traditional | PDF ↗ |
| K210487 | MIPLNI YK-244 Disposable Surgical Mask | Hunan Yuankang Biological Technology Co., Ltd. | 2021-03-16 | Traditional | PDF ↗ |
| K201924 | Single-Use Surgical Mask | Qiqihar Hengxin Medical Supplies, Ltd. | 2021-03-15 | Traditional | PDF ↗ |
| K201698 | Medical Surgical Mask | Hangzhou Mycode Bio-Medicine Co., Ltd. | 2021-03-15 | Traditional | PDF ↗ |
| K203775 | AIC disposable medical mask | The Aleen International Corporation | 2021-03-12 | Traditional | PDF ↗ |
| K202161 | Surgical Face Mask | Hunan Eexi Technology & Service Co., Ltd. | 2021-03-10 | Traditional | PDF ↗ |
| K202548 | Surgical Face Mask | Wanxinda (Guangzhou) Technology Product Co., Ltd. | 2021-03-10 | Traditional | PDF ↗ |
| K202411 | Surgical Mask | Allmed Medical Products Co., Ltd. | 2021-03-10 | Traditional | PDF ↗ |
| K202710 | Disposable Medical Face Mask | Wanxinda (Guangzhou) Technology Product Co., Ltd. | 2021-03-09 | Traditional | PDF ↗ |
| K202205 | Surgical Face Mask | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-03-09 | Traditional | PDF ↗ |
| K210181 | Nordiwell Surgical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | 2021-03-09 | Special | PDF ↗ |
| K202409 | Surgical Mask | Allmed Medical Products Co., Ltd. | 2021-03-09 | Traditional | PDF ↗ |
| K202439 | Disposable Medical Face Mask | Hunan Eexi Technology & Service Co., Ltd. | 2021-03-08 | Traditional | PDF ↗ |
| K201974 | Single-use medical face mask | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2021-03-07 | Traditional | PDF ↗ |
| K203425 | Surgical Mask | Bdc Dental Corporation , Ltd. | 2021-03-05 | Traditional | PDF ↗ |
| K210225 | Surgical Face Mask | Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. | 2021-03-04 | Traditional | PDF ↗ |
| K202137 | Disposable medical mask | U-Play Products Corporation | 2021-03-04 | Traditional | PDF ↗ |
| K202316 | Medical mask (Model: KKF-1A) | Han Zhaoqing Sporting Goods Company Limited | 2021-03-03 | Traditional | PDF ↗ |
| K201852 | Surgical Mask-Model Number: Ear Loop, Flat-Pleated | Huizhou Foryou Medical Devices Co., Ltd. | 2021-03-02 | Abbreviated | PDF ↗ |
| K202214 | IFM Surgical Mask Model SM3 | Fssc, LLC | 2021-03-02 | Traditional | PDF ↗ |
| K203524 | Surgical Masks | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2021-02-25 | Traditional | PDF ↗ |
| K202240 | Disposable Surgical Mask/Fluid Resistant Procedure Mask | Lhm Medical Technology (Hong Kong) Limited | 2021-02-25 | Traditional | PDF ↗ |
| K201868 | Phyziofit Medical Surgical Mask | Wellpower Sporting Goods Co., Ltd. | 2021-02-22 | Traditional | PDF ↗ |
| K201182 | iMask Disposable Surgical Face Mask | Pac-Dent, Inc. | 2021-02-19 | Traditional | PDF ↗ |
| K203426 | Surgical Face Mask (non-sterile) | Nantong Taiweishi Medical Technology Co., Ltd. | 2021-02-18 | Traditional | PDF ↗ |
| K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On | Dukal Corporation | 2021-02-16 | Traditional | PDF ↗ |
| K201545 | Surgical Face Mask | Amphastar Nanjing Pharmaceuticals, Inc. | 2021-02-12 | Abbreviated | PDF ↗ |
| K202341 | Disposable Surgical Mask | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2021-02-12 | Traditional | PDF ↗ |
| K202605 | Standard Procedure Mask, Standard Surgical Mask | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | 2021-02-10 | Traditional | PDF ↗ |
| K203265 | nPro Surgical Mask | Np Medical, Inc. | 2021-02-09 | Abbreviated | PDF ↗ |
| K210063 | Freudenberg Surgical Mask | Freudenberg Performance Materials LP | 2021-02-05 | Traditional | PDF ↗ |
| 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 | 2021-02-05 | Traditional | PDF ↗ |
| K202493 | Medical Face Mask | Gemtier Medical (Shanghai), Inc. | 2021-02-04 | Traditional | PDF ↗ |
| K202627 | Medical Face Masks | Guilin Hbm Sanitary Protections, Inc. | 2021-02-03 | Traditional | PDF ↗ |
| K202096 | 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On | Ecoguard, Inc. | 2021-02-02 | Traditional | PDF ↗ |
| K202323 | Disposable Medical Surgical Masks | Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd. | 2021-02-02 | Traditional | PDF ↗ |
| K202511 | Disposable Medical Surgical Mask | Improve Medical (Hunan) Co., Ltd. | 2021-02-02 | Traditional | PDF ↗ |
| K202331 | Medical Face Mask | Gemtier Medical (Shanghai), Inc. | 2021-02-02 | Traditional | PDF ↗ |
| K202358 | Protective Face Mask for Medical Use | Hunan Heng Chang Pharmaceutical Co., Ltd. | 2021-01-29 | Traditional | PDF ↗ |
| K202640 | Surgical Mask | Jiangsu Medpure Biological Technology Co., Ltd. | 2021-01-22 | Traditional | PDF ↗ |
| K202904 | Surgical Face Mask | Jiangxi Feilikang Medical Technology Co., Ltd. | 2021-01-21 | Traditional | PDF ↗ |
| K202595 | Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask | Premier Guard USA, LLC | 2021-01-21 | Traditional | PDF ↗ |
| K202107 | Medical Protective Mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021-01-15 | Traditional | PDF ↗ |
| K202314 | Procedure face mask (Model: KKF-2A) | Han Zhaoqing Sporting Goods Company Limited | 2021-01-13 | Traditional | PDF ↗ |
| K202843 | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2021-01-12 | Traditional | PDF ↗ |
| K201625 | Disposable Medical Surgical Mask | Tianjin Saiyuan Technology Co., Ltd. | 2021-01-12 | Abbreviated | PDF ↗ |
| K202577 | Medical Surgical Mask-Model MP002-5, MP002-6 | Jiangmen Sure&Me Medical Product Co., Ltd. | 2021-01-11 | Traditional | PDF ↗ |
| K202594 | Medical Surgical Masks-Non Sterile | Shandong T&F Nonwoven Co., Ltd. | 2021-01-06 | Traditional | PDF ↗ |
| K202491 | Disposable Surgical Face Mask | Jiangsu Newvalue Medical Products Co., Ltd. | 2021-01-06 | Traditional | PDF ↗ |
| K202719 | Disposable Medical Face Masks | Jiangxi Sanxin Medtec Co., Ltd. | 2021-01-04 | Traditional | PDF ↗ |
| K202615 | Nordiwell Medical Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | 2020-12-31 | Traditional | PDF ↗ |
| K201754 | JianYu Surgical Mask | Jiangsu Jianyu Health Medical Co., Ltd. | 2020-12-30 | Traditional | PDF ↗ |
| K202061 | Medical Face mask | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | 2020-12-23 | Traditional | PDF ↗ |
| K202211 | Disposable Medical Surgical Face Masks | Guangdong Kaidi Garments Co.,Ltd | 2020-12-22 | Traditional | PDF ↗ |
| K202029 | Medical Surgical Mask | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020-12-16 | Traditional | PDF ↗ |
| K201629 | Medical Face Mask | Shandong Shengquan New Material Co., Ltd. | 2020-12-14 | Traditional | PDF ↗ |
| K201893 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co., Ltd. | 2020-12-09 | Traditional | PDF ↗ |
| K201729 | Medical Mask | Zhende Medical Co., Ltd. | 2020-12-03 | Traditional | PDF ↗ |
| K202069 | BASE4 Disposable Medical Mask | Base4 Group, Inc. | 2020-12-01 | Abbreviated | PDF ↗ |
| K201622 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020-11-24 | Traditional | PDF ↗ |
| K201991 | Medical surgical mask | Shenzhen Everwin Precision Technology Co., Ltd. | 2020-11-23 | Traditional | PDF ↗ |
| K202139 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020-11-20 | Traditional | PDF ↗ |
| K201380 | Livocare Surgical Mask | Andon Health Co, Ltd. | 2020-10-07 | Abbreviated | PDF ↗ |
| K202277 | Surgical Face Mask | Jiangxi 3l Medical Products Group Co., Ltd. | 2020-09-25 | Traditional | PDF ↗ |
| K202463 | Disposable Surgical Mask | Unisources Group, LLC | 2020-09-18 | Traditional | PDF ↗ |
| K201691 | Single-Use Surgical Mask With Ear Loop | Qiqihar Hengxin Medical Supplies, Ltd. | 2020-09-17 | Traditional | PDF ↗ |
| K202354 | Surgical Mask-Model Number CW01 | Hunan Heng Chang Pharmaceutical Co., Ltd. | 2020-09-08 | Traditional | PDF ↗ |
| K201470 | Disposable Medical Face Mask | Jkh USA, LLC | 2020-09-08 | Traditional | PDF ↗ |
| K201517 | Plain Surgical Mask | Aok Tooling Limited | 2020-09-04 | Traditional | PDF ↗ |
| K201537 | Protective Face Mask for Medical Use | Shandong Shengquan New Material Co., Ltd. | 2020-09-04 | Traditional | PDF ↗ |
| K200923 | Single-use Surgical Mask | Byd Precision Manufacturer Co., Ltd. | 2020-08-26 | Traditional | PDF ↗ |
| K201549 | Motex Anti-Fog Surgical Face Mask | Modern Healthcare Corp. | 2020-08-26 | Traditional | PDF ↗ |
| K201137 | Asept Surgical Face Mask | Pfm Medical, Inc. | 2020-08-19 | Abbreviated | PDF ↗ |
| K201871 | Surgical Mask | C & S Paper Yunfu Co., Ltd. | 2020-08-12 | Traditional | PDF ↗ |
| K201479 | DemeMASK | Demetech Corporation | 2020-07-24 | Abbreviated | PDF ↗ |
| K200847 | Surgical Face Mask | Mexpo International, Inc. | 2020-04-23 | Traditional | PDF ↗ |
| K200576 | ClearMask Transparent Surgical Face Mask | Clearmask, LLC | 2020-04-06 | Abbreviated | PDF ↗ |
| K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip | Cardinal Health200, LLC | 2019-12-02 | Traditional | PDF ↗ |
| K191355 | 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask | 3M Healthcare | 2019-09-11 | Traditional | PDF ↗ |
| K182515 | Surgical Face Mask | Wuhan Dymex Healthcare Co., Ltd. | 2019-05-27 | Traditional | PDF ↗ |
| K182514 | Surgical Face Mask | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2019-01-24 | Traditional | PDF ↗ |
| K180874 | 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield | 3M Healthcare | 2018-07-31 | Traditional | PDF ↗ |
| K172500 | Technoweb Surgical Mask | Yts Global, Inc. | 2018-03-01 | Traditional | PDF ↗ |
| K173062 | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) | V&Q Manufacturing Corporation | 2018-01-25 | Traditional | PDF ↗ |
| K171162 | Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield | Prestige Ameritech | 2017-08-15 | Abbreviated | PDF ↗ |
| K153409 | Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) | Protect U Guard, LLC | 2016-11-15 | Abbreviated | PDF ↗ |
| K160269 | Surgical Face Masks (Ear loops and Tie-on) | San-M Package Co., Ltd. | 2016-09-06 | Abbreviated | PDF ↗ |
| K152197 | Skypro, SP01 Mask | Skypro Medical Supplies Company | 2016-08-26 | Traditional | PDF ↗ |
| K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | 2016-06-15 | Traditional | PDF ↗ |
| K152561 | Communicator Surgical Facemask with Clear Window | Prestige Ameritech , Ltd. | 2016-06-03 | Abbreviated | PDF ↗ |
| K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | Bh Medical Products Co., Ltd. | 2015-06-22 | Traditional | PDF ↗ |
| K141875 | Pasture 60S Surgical Mask | Pasture Pharma Pte, Ltd. | 2015-05-05 | Traditional | PDF ↗ |
| K141085 | WestTec Procedure Facemask;WestTec Surgical Facemask | Westtec, LLC | 2015-03-27 | Traditional | PDF ↗ |
Product code FXX · Class II · General, Plastic Surgery. Data: openFDA.