Panels › General, Plastic Surgery › Product code FXX · Class 2
Mask, Surgical
Regulation 878.4040
7510(k)s in 12 months (607 all time)
0recalls in 12 months (12 all time)
10recalls that name a 510(k)
Top companies in FXX
| Company | 510(k)s | Recalls |
|---|---|---|
| Tecnol New Jersey Wound Care, Inc. | 11 | 0 |
| Owens & Minor (O&M) Halyard, Inc. | 8 | 0 |
| Anago, Inc. | 7 | 0 |
| Protectaide, Inc. | 7 | 0 |
| 3M Company | 6 | 0 |
| Guangdong Kingfa Sci. & Tech.Co., Ltd. | 6 | 0 |
| AMD Medicom Inc. | 0 | 5 |
| Tecnol Medical Products, Inc. | 5 | 0 |
| Dukal Corp. | 4 | 0 |
| Kimberly-Clark | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2021 | K202314 | Procedure face mask (Model: KKF-2A) Han Zhaoqing Sporting Goods Company Limited, CN | FXX |
| Jan 12, 2021 | K202843 | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd., CN | FXX |
| Jan 12, 2021 | K201625 | Disposable Medical Surgical Mask Tianjin Saiyuan Technology Co., Ltd., CN | FXX |
| Jan 11, 2021 | K202577 | Medical Surgical Mask-Model MP002-5, MP002-6 Jiangmen Sure&Me Medical Product Co., Ltd., CN | FXX |
| Jan 6, 2021 | K202594 | Medical Surgical Masks-Non Sterile Shandong T&F Nonwoven Co., Ltd., CN | FXX |
| Jan 6, 2021 | K202491 | Disposable Surgical Face Mask Jiangsu Newvalue Medical Products Co., Ltd., CN | FXX |
| Jan 4, 2021 | K202719 | Disposable Medical Face Masks Jiangxi Sanxin Medtec Co., Ltd., CN | FXX |
| Dec 31, 2020 | K202615 | Nordiwell Medical Face Mask Changzhou Combat Protective Equipment Co., Ltd., CN | FXX |
| Dec 30, 2020 | K201754 | JianYu Surgical Mask Jiangsu Jianyu Health Medical Co., Ltd., CN | FXX |
| Dec 23, 2020 | K202061 | Medical Face mask Jiangsu Province Jianerkang Medical Dressing Co., Ltd., CN | FXX |
| Dec 22, 2020 | K202211 | Disposable Medical Surgical Face Masks Guangdong Kaidi Garments Co.,Ltd, CN | FXX |
| Dec 16, 2020 | K202029 | Medical Surgical Mask Beijing Biosis Healing Biolog Ical Technology Co., Ltd., CN | FXX |
| Dec 14, 2020 | K201629 | Medical Face Mask Shandong Shengquan New Material Co., Ltd., CN | FXX |
| Dec 9, 2020 | K201893 | Disposable Surgical Mask Xiamen Probtain Medical Techology Co., Ltd., CN | FXX |
| Dec 3, 2020 | K201729 | Medical Mask Zhende Medical Co., Ltd., CN | FXX |
| Dec 1, 2020 | K202069 | BASE4 Disposable Medical Mask Base4 Group, Inc. | FXX |
| Nov 24, 2020 | K201622 | Medical surgical mask Guangdong Kingfa Sci. & Tech.Co., Ltd., CN | FXX |
| Nov 23, 2020 | K201991 | Medical surgical mask Shenzhen Everwin Precision Technology Co., Ltd., CN | FXX |
| Nov 20, 2020 | K202139 | Medical surgical mask Guangdong Kingfa Sci. & Tech.Co., Ltd., CN | FXX |
| Oct 7, 2020 | K201380 | Livocare Surgical Mask Andon Health Co, Ltd., CN | FXX |
| Sep 25, 2020 | K202277 | Surgical Face Mask Jiangxi 3l Medical Products Group Co., Ltd., CN | FXX |
| Sep 18, 2020 | K202463 | Disposable Surgical Mask Unisources Group, LLC | FXX |
| Sep 17, 2020 | K201691 | Single-Use Surgical Mask With Ear Loop Qiqihar Hengxin Medical Supplies, Ltd., CN | FXX |
| Sep 8, 2020 | K202354 | Surgical Mask-Model Number CW01 Hunan Heng Chang Pharmaceutical Co., Ltd., CN | FXX |
| Sep 8, 2020 | K201470 | Disposable Medical Face Mask Jkh USA, LLC | FXX |
| Sep 4, 2020 | K201537 | Protective Face Mask for Medical Use Shandong Shengquan New Material Co., Ltd., CN | FXX |
| Sep 4, 2020 | K201517 | Plain Surgical Mask Aok Tooling Limited, CN | FXX |
| Aug 26, 2020 | K201549 | Motex Anti-Fog Surgical Face Mask Modern Healthcare Corp., TW | FXX |
| Aug 26, 2020 | K200923 | Single-use Surgical Mask Byd Precision Manufacturer Co., Ltd., CN | FXX |
| Aug 19, 2020 | K201137 | Asept Surgical Face Mask Pfm Medical, Inc. | FXX |
| Aug 12, 2020 | K201871 | Surgical Mask C & S Paper Yunfu Co., Ltd., CN | FXX |
| Jul 24, 2020 | K201479 | DemeMASK Demetech Corporation | FXX |
| Apr 23, 2020 | K200847 | Surgical Face Mask Mexpo International, Inc. | FXX |
| Apr 6, 2020 | K200576 | ClearMask Transparent Surgical Face Mask Clearmask, LLC | FXX |
| Dec 2, 2019 | K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip Cardinal Health200, LLC | FXX |
| Sep 11, 2019 | K191355 | 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask 3M Healthcare | FXX |
| May 27, 2019 | K182515 | Surgical Face Mask Wuhan Dymex Healthcare Co., Ltd., CN | FXX |
| Jan 24, 2019 | K182514 | Surgical Face Mask Xiantao Zhibo Non-Woven Products Co., Ltd., CN | FXX |
| Jul 31, 2018 | K180874 | 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield 3M Healthcare | FXX |
| Mar 1, 2018 | K172500 | Technoweb Surgical Mask Yts Global, Inc. | FXX |
| Jan 25, 2018 | K173062 | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) V&Q Manufacturing Corporation, CN | FXX |
| Aug 15, 2017 | K171162 | Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield Prestige Ameritech | FXX |
| Nov 15, 2016 | K153409 | Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) Protect U Guard, LLC | FXX |
| Sep 6, 2016 | K160269 | Surgical Face Masks (Ear loops and Tie-on) San-M Package Co., Ltd., JP | FXX |
| Aug 26, 2016 | K152197 | Skypro, SP01 Mask Skypro Medical Supplies Company, CN | FXX |
| Jun 15, 2016 | K153496 | Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., Ltd., CN | FXX |
| Jun 3, 2016 | K152561 | Communicator Surgical Facemask with Clear Window Prestige Ameritech , Ltd. | FXX |
| Jun 22, 2015 | K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) Bh Medical Products Co., Ltd. | FXX |
| May 5, 2015 | K141875 | Pasture 60S Surgical Mask Pasture Pharma Pte, Ltd. | FXX |
| Mar 27, 2015 | K141085 | WestTec Procedure Facemask;WestTec Surgical Facemask Westtec, LLC | FXX |
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