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 |
|---|---|---|---|
| Dec 13, 2021 | K202794 | Surgical face mask: F-Y1-A Jiande Chaomei Daily Chemicals Co., Ltd., CN | FXX |
| Dec 11, 2021 | K212867 | Medical Surgical Mask Nanchang Kanghua Health Materials Co., Ltd., CN | FXX |
| Dec 8, 2021 | K211487 | MAF Guard Maf Clothing Pvt Ltd Unit-3, IN | FXX |
| Dec 7, 2021 | K212302 | BAYLAB 3-Ply Surgical Mask (BEACON I) Baylab USA, LLC | FXX |
| Dec 6, 2021 | K212235 | Surgical Face Mask Shanghai Yunqing Industrial Co., Ltd., CN | FXX |
| Dec 6, 2021 | K211772 | PMW01 Procedure Mask Level 1 Defender Safety, Inc. | FXX |
| Dec 3, 2021 | K212807 | Surgical Masks Weihai Hongyu Nonwoven Fabric Products Co., Ltd., CN | FXX |
| Dec 2, 2021 | K212740 | Puravita Medical Fold Flat Surgical Mask Puravita M, LLC | FXX |
| Dec 2, 2021 | K211773 | Single-use Surgical Mask Taiwan Seafood and Fish Corporation | FXX |
| Nov 30, 2021 | K211696 | Disposable Surgical Face Mask Anhui Cleanpro Pharmpack Co., Ltd., CN | FXX |
| Nov 26, 2021 | K202842 | Medical surgical mask Henan Huibo Medical Co., Ltd., CN | FXX |
| Nov 24, 2021 | K211295 | Surgical Mask (sterile) Nanjing 3h Medical Products Co., Ltd., CN | FXX |
| Nov 23, 2021 | K211956 | 039 Surgical Face Mask Aok Tooling Limited, CN | FXX |
| Nov 18, 2021 | K213406 | Savvy Mask - Level 3 Surgical Face Mask Texas Medplast, LLC | FXX |
| Nov 18, 2021 | K212046 | Impertech Surgical Face Mask Impertech Industries , Ltd., IL | FXX |
| Nov 17, 2021 | K210042 | Disposable Surgical Mask Suzhou Letian Protective Products Co., Ltd., CN | FXX |
| Nov 16, 2021 | K212344 | Surgical Mask Xiantao Dingcheng Non-Woven Product Co., Ltd., CN | FXX |
| Nov 14, 2021 | K212575 | Surgical Face Mask Hubei Huanfu Plastic Products Co., Ltd., CN | FXX |
| Nov 14, 2021 | K212109 | Spin Care Disposable Protective Mask Level 3 Spintech, LLC | FXX |
| Nov 13, 2021 | K212264 | Surgical Face mask Nantong Taiweishi Medical Technology Co., Ltd., CN | FXX |
| Nov 9, 2021 | K212526 | Surgical Face Mask Suzhou Janee Medical Technology Co., Ltd., CN | FXX |
| Nov 9, 2021 | K211165 | Medical Face Masks, Model Name:MY020003 Huizhou Jie Bai Purification Co., Ltd., CN | FXX |
| Nov 5, 2021 | K212460 | Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) Guangzhou Zhengkang Medical Equipment Co.,Ltd, CN | FXX |
| Nov 5, 2021 | K202676 | Disposable Medical Face Mask Zhejiang Senhong Medical&Instrument Co., Ltd., CN | FXX |
| Nov 4, 2021 | K212471 | Medical Face Mask Haian Medigauze Co., Ltd., CN | FXX |
| Nov 2, 2021 | K210222 | Disposable Medical Mask Guangdong Lide Medical Technology Co., Ltd., CN | FXX |
| Oct 25, 2021 | K212293 | Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) Jiangmen Ningrui Medical Supplies Co., Ltd., CN | FXX |
| Oct 24, 2021 | K212368 | Surgical Face Mask Anhui Tiankang Medical Technology Co., Ltd., CN | FXX |
| Oct 24, 2021 | K210348 | Disposable Medical Surgical Mask Weihai Dishang Medical Technology Co., Ltd., CN | FXX |
| Oct 19, 2021 | K203565 | Surgical 3D Mask Inno Lifecare, CA | FXX |
| Oct 14, 2021 | K212205 | Medical Protective Masks Qinhuangdao Taizhi Medical Technology Co., Ltd., CN | FXX |
| Oct 12, 2021 | K210845 | Disposable Surgical Mask (Model: YYKZ-01) Jiaxing Amazing Travel-Ware Co., Ltd., CN | FXX |
| Oct 8, 2021 | K210813 | Medical Surgical Mask Sichuan Pharmaceutical., Inc., CN | FXX |
| Oct 8, 2021 | K210622 | Single-Use Medical Face Mask Jiangxi Hongda Medical Equipment Group Co., Ltd., CN | FXX |
| Oct 4, 2021 | K211899 | Surgical Face Mask Hubei Yi-Ya Protective Products Co., Ltd., CN | FXX |
| Oct 4, 2021 | K211425 | Private Stock Labs Surgical Face Mask J.K. Private Stock, Inc. | FXX |
| Sep 29, 2021 | K210513 | UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 Universal Incorporation, TW | FXX |
| Sep 28, 2021 | K211794 | Disposable surgical mask Shanghai No.9 Knitting Mill Co., Ltd., CN | FXX |
| Sep 28, 2021 | K210878 | Surgical Face Mask (Model: CM2006, CM2008, A88) Shenzhen Realtone Medical Appliance Co., Ltd., CN | FXX |
| Sep 26, 2021 | K210908 | Surgical Mask Sichuan Prius Biotechnology Co., Ltd., CN | FXX |
| Sep 23, 2021 | K211827 | Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) Zhejiang Lanhine Medical Products, Ltd., CN | FXX |
| Sep 22, 2021 | K211097 | Banyan USA Surgical Mask Level 3 Banyan USA, LLC | FXX |
| Sep 22, 2021 | K210772 | 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) Vr Vertical, LLC Dba Xrgo | FXX |
| Sep 17, 2021 | K211751 | WELLTRUST WT-III Mask with Flat Earloop Lonestar Meadows, LLC | FXX |
| Sep 17, 2021 | K203418 | Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) Ningbo Ouhan Medical Device Co., Ltd., CN | FXX |
| Sep 16, 2021 | K203112 | Disposable Medical Mask Yangzhou Runyi Arts & Crafts Co., Ltd., CN | FXX |
| Sep 14, 2021 | K210184 | Wilson Tech Disposable Medical Face Mask Wilson Tech (International) Limited, HK | FXX |
| Sep 13, 2021 | K203455 | Disposable Medical Mask Fujian Kang Chen Daily Necessities Co., Ltd., CN | FXX |
| Sep 11, 2021 | K211296 | Surgical face mask Sunsmed Protective Products , Ltd., CN | FXX |
| Sep 10, 2021 | K212451 | Surgical Mask Remade USA, LLC | FXX |
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