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 2 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220512 | Disposable Surgical Face Mask (M01, M02) | Fomed Industries, Inc. | 2022-04-25 | Traditional | PDF ↗ |
| K212203 | Dong Hai Xiang Surgical Mask | Taizhou Donghaixiang Protective Equipment Co., Ltd. | 2022-04-07 | Traditional | PDF ↗ |
| K210860 | Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 | Gri-Alleset, Inc. | 2022-04-07 | Traditional | PDF ↗ |
| K214085 | Disposable Medical Mask | Hubei Wanli Protective Products Co., Ltd. | 2022-04-06 | Traditional | PDF ↗ |
| K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-04-05 | Traditional | PDF ↗ |
| K213736 | Medical Face Mask | Hangzhou Runheng Medical Co., Ltd. | 2022-03-31 | Traditional | PDF ↗ |
| K210422 | INTAI Surgical Mask (non-sterile) | Intai Technology Corp. | 2022-03-30 | Traditional | PDF ↗ |
| K220187 | Medical Surgical Mask (Model: JM92, JM92B) | Guangdong Jia Mei Biological Technology Co.Ltd | 2022-03-25 | Traditional | PDF ↗ |
| K220637 | 3 Ply Medical Grade Single Use Procedural Disposable Face Mask | Kdi Med Supply | 2022-03-25 | Traditional | PDF ↗ |
| K202903 | Surgical Face Mask | Rizhao Sanqi Medical & Health Articles Co., Ltd. | 2022-03-24 | Traditional | PDF ↗ |
| K212726 | Disposable Medical Surgical Mask | Hubei Huaqiang High-Tech Co., Ltd. | 2022-03-23 | Traditional | PDF ↗ |
| K213894 | DWFritz ASM2000 | Dwfritz Automation, Inc. | 2022-03-14 | Traditional | PDF ↗ |
| K212330 | Yadu Medical Face Mask (Level 1) | Henan Yadu Industrial Co., Ltd. | 2022-03-14 | Traditional | PDF ↗ |
| K213806 | Disposable Medical Face Mask | Xiantao Zhibo Nonwoven Products Co., Ltd. | 2022-03-12 | Traditional | PDF ↗ |
| K214087 | Medical Face Mask | Hubei Medlink Healthcare Co., Ltd. | 2022-03-08 | Traditional | PDF ↗ |
| K213358 | Surgical Mask | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2022-03-04 | Traditional | PDF ↗ |
| K203376 | ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G | Medtecs (Taiwan) Corp. | 2022-03-02 | Traditional | PDF ↗ |
| K214094 | ROKI Surgical Mask | Roki Co., Ltd. | 2022-02-24 | Traditional | PDF ↗ |
| K213724 | Medical Surgical Mask | Hunan Zhenheyikang Medical Instrument Co., Ltd. | 2022-02-20 | Traditional | PDF ↗ |
| K212863 | Surgical Face Mask | Taiwan Comfort Champ Manufacturing Co., Ltd. | 2022-02-19 | Traditional | PDF ↗ |
| K212366 | Heartland Health Surgical Mask | Heartland Health Products | 2022-02-19 | Abbreviated | PDF ↗ |
| K213617 | Surgical Face Mask | Megasoft (China) Co., Ltd. | 2022-02-11 | Traditional | PDF ↗ |
| K212120 | Surgical Masks | Hubei Xinxin Non-Woven Co., Ltd. | 2022-01-28 | Traditional | PDF ↗ |
| K212610 | Surgical Face Mask | Foshan Nanhai Plus Medical Co, Ltd. | 2022-01-26 | Traditional | PDF ↗ |
| K210101 | American-Made Surgical Mask | Armbrust, Inc. | 2022-01-26 | Abbreviated | PDF ↗ |
| K213347 | ADI Medical Surgical Face Mask | Asia Dynamics Inc., D/B/A Adi Medical | 2022-01-25 | Traditional | PDF ↗ |
| K213970 | D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply | Danameco Medical Joint Stock Corporation | 2022-01-23 | Traditional | PDF ↗ |
| K212111 | Myflon Surgical Mask Level 3 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi | 2022-01-23 | Traditional | PDF ↗ |
| K203161 | Surgical Face Mask | Wuhan Raytex Protection Co., Ltd. | 2022-01-20 | Traditional | PDF ↗ |
| K212826 | Disposable Medical Mask | Jiangsu Nanfang Medical Co., Ltd. | 2022-01-19 | Traditional | PDF ↗ |
| K210679 | Medical Face Mask | Wuxi Yushou Medical Appliances Co., Ltd. | 2022-01-18 | Traditional | PDF ↗ |
| K212994 | Medical Face Mask | Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. | 2022-01-17 | Traditional | PDF ↗ |
| K213920 | Kangbeier Surgical Mask (Model: KBR-1001) | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2022-01-16 | Traditional | PDF ↗ |
| K211833 | Disposable Medical Face Mask | Zhejiang the Purples Protective Products Co.,Ltd | 2022-01-16 | Traditional | PDF ↗ |
| K212997 | Surgical Mask | Guangdong Zhizhen Biological Medical Co., Ltd. | 2022-01-14 | Traditional | PDF ↗ |
| K212913 | Surgical Face Mask | Jiangxi Ganlong Pharmaceutical Co., Ltd. | 2022-01-14 | Traditional | PDF ↗ |
| K211260 | Sheng Jing Tang Surgical Mask | Liaoning Shengjingtang Biotechnology Co., Ltd. | 2022-01-10 | Traditional | PDF ↗ |
| K212375 | Disposable Medical Surgical Mask | Jiangxi Bestgrand Health Technology Co., Ltd. | 2022-01-04 | Traditional | PDF ↗ |
| K212299 | Medical Surgical Mask | Wepon Medical Technology Co., Ltd. | 2022-01-04 | Traditional | PDF ↗ |
| K202255 | Skypro, SP02 Mask (3) | Skypro Medical Supplies Company | 2021-12-24 | Traditional | PDF ↗ |
| K213136 | CPL Surgical Face Mask | Control Print Limited | 2021-12-24 | Traditional | PDF ↗ |
| K210147 | Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield | Unicoglobal, Inc. | 2021-12-22 | Traditional | PDF ↗ |
| K211750 | Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) | National Bridge Industrial (S.Z.) Co., Ltd. | 2021-12-20 | Traditional | PDF ↗ |
| K212059 | Surgical Face Mask | Zhongshan Saifute Labor Protective Articles Co., Ltd. | 2021-12-17 | Traditional | PDF ↗ |
| K210102 | Topwide Surgical Face Mask | Topwide (Hubei) Medical Products Manufacturer | 2021-12-17 | Traditional | PDF ↗ |
| K211378 | LM Surgical Mask Level 3, LM Surgical Mask Level 2, | Liberty Mask, LLC | 2021-12-16 | Traditional | PDF ↗ |
| K212944 | Disposable Surgical Mask | Heilongjiang Yinjia Medical Equipment Co., Ltd. | 2021-12-15 | Traditional | PDF ↗ |
| K212398 | Surgical Face Mask (Non-sterile) | Hubei Kimsoul Industrial Co., Ltd. | 2021-12-15 | Traditional | PDF ↗ |
| K212574 | Surgical Face Mask | Xiantao Deming Healthcare Products Co., Ltd. | 2021-12-14 | Traditional | PDF ↗ |
| K210744 | Surgical Mask | Chongqing PA Xijia Biotechnology Co., Ltd. | 2021-12-14 | Traditional | PDF ↗ |
| K202794 | Surgical face mask: F-Y1-A | Jiande Chaomei Daily Chemicals Co., Ltd. | 2021-12-13 | Traditional | PDF ↗ |
| K212867 | Medical Surgical Mask | Nanchang Kanghua Health Materials Co., Ltd. | 2021-12-11 | Traditional | PDF ↗ |
| K211487 | MAF Guard | Maf Clothing Pvt Ltd Unit-3 | 2021-12-08 | Abbreviated | PDF ↗ |
| K212302 | BAYLAB 3-Ply Surgical Mask (BEACON I) | Baylab USA, LLC | 2021-12-07 | Traditional | PDF ↗ |
| K211772 | PMW01 Procedure Mask Level 1 | Defender Safety, Inc. | 2021-12-06 | Abbreviated | PDF ↗ |
| K212235 | Surgical Face Mask | Shanghai Yunqing Industrial Co., Ltd. | 2021-12-06 | Traditional | PDF ↗ |
| K212807 | Surgical Masks | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2021-12-03 | Traditional | PDF ↗ |
| K211773 | Single-use Surgical Mask | Taiwan Seafood and Fish Corporation | 2021-12-02 | Traditional | PDF ↗ |
| K212740 | Puravita Medical Fold Flat Surgical Mask | Puravita M, LLC | 2021-12-02 | Traditional | PDF ↗ |
| K211696 | Disposable Surgical Face Mask | Anhui Cleanpro Pharmpack Co., Ltd. | 2021-11-30 | Traditional | PDF ↗ |
| K202842 | Medical surgical mask | Henan Huibo Medical Co., Ltd. | 2021-11-26 | Traditional | PDF ↗ |
| K211295 | Surgical Mask (sterile) | Nanjing 3h Medical Products Co., Ltd. | 2021-11-24 | Traditional | PDF ↗ |
| K211956 | 039 Surgical Face Mask | Aok Tooling Limited | 2021-11-23 | Traditional | PDF ↗ |
| K213406 | Savvy Mask - Level 3 Surgical Face Mask | Texas Medplast, LLC | 2021-11-18 | Traditional | PDF ↗ |
| K212046 | Impertech Surgical Face Mask | Impertech Industries , Ltd. | 2021-11-18 | Traditional | PDF ↗ |
| K210042 | Disposable Surgical Mask | Suzhou Letian Protective Products Co., Ltd. | 2021-11-17 | Traditional | PDF ↗ |
| K212344 | Surgical Mask | Xiantao Dingcheng Non-Woven Product Co., Ltd. | 2021-11-16 | Traditional | PDF ↗ |
| K212575 | Surgical Face Mask | Hubei Huanfu Plastic Products Co., Ltd. | 2021-11-14 | Traditional | PDF ↗ |
| K212109 | Spin Care Disposable Protective Mask Level 3 | Spintech, LLC | 2021-11-14 | Traditional | PDF ↗ |
| K212264 | Surgical Face mask | Nantong Taiweishi Medical Technology Co., Ltd. | 2021-11-13 | Traditional | PDF ↗ |
| K212526 | Surgical Face Mask | Suzhou Janee Medical Technology Co., Ltd. | 2021-11-09 | Traditional | PDF ↗ |
| K211165 | Medical Face Masks, Model Name:MY020003 | Huizhou Jie Bai Purification Co., Ltd. | 2021-11-09 | Traditional | PDF ↗ |
| K202676 | Disposable Medical Face Mask | Zhejiang Senhong Medical&Instrument Co., Ltd. | 2021-11-05 | Traditional | PDF ↗ |
| K212460 | Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) | Guangzhou Zhengkang Medical Equipment Co.,Ltd | 2021-11-05 | Traditional | PDF ↗ |
| K212471 | Medical Face Mask | Haian Medigauze Co., Ltd. | 2021-11-04 | Traditional | PDF ↗ |
| K210222 | Disposable Medical Mask | Guangdong Lide Medical Technology Co., Ltd. | 2021-11-02 | Traditional | PDF ↗ |
| K212293 | Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) | Jiangmen Ningrui Medical Supplies Co., Ltd. | 2021-10-25 | Traditional | PDF ↗ |
| K212368 | Surgical Face Mask | Anhui Tiankang Medical Technology Co., Ltd. | 2021-10-24 | Traditional | PDF ↗ |
| K210348 | Disposable Medical Surgical Mask | Weihai Dishang Medical Technology Co., Ltd. | 2021-10-24 | Traditional | PDF ↗ |
| K203565 | Surgical 3D Mask | Inno Lifecare | 2021-10-19 | Traditional | PDF ↗ |
| K212205 | Medical Protective Masks | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 2021-10-14 | Traditional | PDF ↗ |
| K210845 | Disposable Surgical Mask (Model: YYKZ-01) | Jiaxing Amazing Travel-Ware Co., Ltd. | 2021-10-12 | Traditional | PDF ↗ |
| K210813 | Medical Surgical Mask | Sichuan Pharmaceutical., Inc. | 2021-10-08 | Traditional | PDF ↗ |
| K210622 | Single-Use Medical Face Mask | Jiangxi Hongda Medical Equipment Group Co., Ltd. | 2021-10-08 | Traditional | PDF ↗ |
| K211899 | Surgical Face Mask | Hubei Yi-Ya Protective Products Co., Ltd. | 2021-10-04 | Traditional | PDF ↗ |
| K211425 | Private Stock Labs Surgical Face Mask | J.K. Private Stock, Inc. | 2021-10-04 | Traditional | PDF ↗ |
| K210513 | UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 | Universal Incorporation | 2021-09-29 | Traditional | PDF ↗ |
| K210878 | Surgical Face Mask (Model: CM2006, CM2008, A88) | Shenzhen Realtone Medical Appliance Co., Ltd. | 2021-09-28 | Traditional | PDF ↗ |
| K211794 | Disposable surgical mask | Shanghai No.9 Knitting Mill Co., Ltd. | 2021-09-28 | Traditional | PDF ↗ |
| K210908 | Surgical Mask | Sichuan Prius Biotechnology Co., Ltd. | 2021-09-26 | Traditional | PDF ↗ |
| K211827 | Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) | Zhejiang Lanhine Medical Products, Ltd. | 2021-09-23 | Traditional | PDF ↗ |
| K210772 | 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) | Vr Vertical, LLC Dba Xrgo | 2021-09-22 | Traditional | PDF ↗ |
| K211097 | Banyan USA Surgical Mask Level 3 | Banyan USA, LLC | 2021-09-22 | Traditional | PDF ↗ |
| K203418 | Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) | Ningbo Ouhan Medical Device Co., Ltd. | 2021-09-17 | Traditional | PDF ↗ |
| K211751 | WELLTRUST WT-III Mask with Flat Earloop | Lonestar Meadows, LLC | 2021-09-17 | Traditional | PDF ↗ |
| K203112 | Disposable Medical Mask | Yangzhou Runyi Arts & Crafts Co., Ltd. | 2021-09-16 | Traditional | PDF ↗ |
| K210184 | Wilson Tech Disposable Medical Face Mask | Wilson Tech (International) Limited | 2021-09-14 | Traditional | PDF ↗ |
| K203455 | Disposable Medical Mask | Fujian Kang Chen Daily Necessities Co., Ltd. | 2021-09-13 | Traditional | PDF ↗ |
| K211296 | Surgical face mask | Sunsmed Protective Products , Ltd. | 2021-09-11 | Traditional | PDF ↗ |
| K212451 | Surgical Mask | Remade USA, LLC | 2021-09-10 | Traditional | PDF ↗ |
Product code FXX · Class II · General, Plastic Surgery. Data: openFDA.