FXX
607 FDA 510(k) clearances · Product code
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Disposable Surgical Face Mask (M01, M02) (K220512) | Fomed Industries, Inc. | 2022-04-25 |
| Dong Hai Xiang Surgical Mask (K212203) | Taizhou Donghaixiang Protective Equipment Co., Ltd. | 2022-04-07 |
| Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 (K210860) | Gri-Alleset, Inc. | 2022-04-07 |
| Disposable Medical Mask (K214085) | Hubei Wanli Protective Products Co., Ltd. | 2022-04-06 |
| Medical surgical mask (Black mask, Level 1 and Level 3) (K213450) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-04-05 |
| Medical Face Mask (K213736) | Hangzhou Runheng Medical Co., Ltd. | 2022-03-31 |
| INTAI Surgical Mask (non-sterile) (K210422) | Intai Technology Corp. | 2022-03-30 |
| Medical Surgical Mask (Model: JM92, JM92B) (K220187) | Guangdong Jia Mei Biological Technology Co.Ltd | 2022-03-25 |
| 3 Ply Medical Grade Single Use Procedural Disposable Face Mask (K220637) | Kdi Med Supply | 2022-03-25 |
| Surgical Face Mask (K202903) | Rizhao Sanqi Medical & Health Articles Co., Ltd. | 2022-03-24 |
| Disposable Medical Surgical Mask (K212726) | Hubei Huaqiang High-Tech Co., Ltd. | 2022-03-23 |
| DWFritz ASM2000 (K213894) | Dwfritz Automation, Inc. | 2022-03-14 |
| Yadu Medical Face Mask (Level 1) (K212330) | Henan Yadu Industrial Co., Ltd. | 2022-03-14 |
| Disposable Medical Face Mask (K213806) | Xiantao Zhibo Nonwoven Products Co., Ltd. | 2022-03-12 |
| Medical Face Mask (K214087) | Hubei Medlink Healthcare Co., Ltd. | 2022-03-08 |
| Surgical Mask (K213358) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2022-03-04 |
| ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G (K203376) | Medtecs (Taiwan) Corp. | 2022-03-02 |
| ROKI Surgical Mask (K214094) | Roki Co., Ltd. | 2022-02-24 |
| Medical Surgical Mask (K213724) | Hunan Zhenheyikang Medical Instrument Co., Ltd. | 2022-02-20 |
| Surgical Face Mask (K212863) | Taiwan Comfort Champ Manufacturing Co., Ltd. | 2022-02-19 |
| Heartland Health Surgical Mask (K212366) | Heartland Health Products | 2022-02-19 |
| Surgical Face Mask (K213617) | Megasoft (China) Co., Ltd. | 2022-02-11 |
| Surgical Masks (K212120) | Hubei Xinxin Non-Woven Co., Ltd. | 2022-01-28 |
| American-Made Surgical Mask (K210101) | Armbrust, Inc. | 2022-01-26 |
| Surgical Face Mask (K212610) | Foshan Nanhai Plus Medical Co, Ltd. | 2022-01-26 |
| ADI Medical Surgical Face Mask (K213347) | Asia Dynamics Inc., D/B/A Adi Medical | 2022-01-25 |
| Myflon Surgical Mask Level 3 (K212111) | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi | 2022-01-23 |
| D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply (K213970) | Danameco Medical Joint Stock Corporation | 2022-01-23 |
| Surgical Face Mask (K203161) | Wuhan Raytex Protection Co., Ltd. | 2022-01-20 |
| Disposable Medical Mask (K212826) | Jiangsu Nanfang Medical Co., Ltd. | 2022-01-19 |
| Medical Face Mask (K210679) | Wuxi Yushou Medical Appliances Co., Ltd. | 2022-01-18 |
| Medical Face Mask (K212994) | Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. | 2022-01-17 |
| Disposable Medical Face Mask (K211833) | Zhejiang the Purples Protective Products Co.,Ltd | 2022-01-16 |
| Kangbeier Surgical Mask (Model: KBR-1001) (K213920) | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2022-01-16 |
| Surgical Face Mask (K212913) | Jiangxi Ganlong Pharmaceutical Co., Ltd. | 2022-01-14 |
| Surgical Mask (K212997) | Guangdong Zhizhen Biological Medical Co., Ltd. | 2022-01-14 |
| Sheng Jing Tang Surgical Mask (K211260) | Liaoning Shengjingtang Biotechnology Co., Ltd. | 2022-01-10 |
| Disposable Medical Surgical Mask (K212375) | Jiangxi Bestgrand Health Technology Co., Ltd. | 2022-01-04 |
| Medical Surgical Mask (K212299) | Wepon Medical Technology Co., Ltd. | 2022-01-04 |
| Skypro, SP02 Mask (3) (K202255) | Skypro Medical Supplies Company | 2021-12-24 |
| CPL Surgical Face Mask (K213136) | Control Print Limited | 2021-12-24 |
| Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield (K210147) | Unicoglobal, Inc. | 2021-12-22 |
| Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) (K211750) | National Bridge Industrial (S.Z.) Co., Ltd. | 2021-12-20 |
| Surgical Face Mask (K212059) | Zhongshan Saifute Labor Protective Articles Co., Ltd. | 2021-12-17 |
| Topwide Surgical Face Mask (K210102) | Topwide (Hubei) Medical Products Manufacturer | 2021-12-17 |
| LM Surgical Mask Level 3, LM Surgical Mask Level 2, (K211378) | Liberty Mask, LLC | 2021-12-16 |
| Surgical Face Mask (Non-sterile) (K212398) | Hubei Kimsoul Industrial Co., Ltd. | 2021-12-15 |
| Disposable Surgical Mask (K212944) | Heilongjiang Yinjia Medical Equipment Co., Ltd. | 2021-12-15 |
| Surgical Face Mask (K212574) | Xiantao Deming Healthcare Products Co., Ltd. | 2021-12-14 |
| Surgical Mask (K210744) | Chongqing PA Xijia Biotechnology Co., Ltd. | 2021-12-14 |
| Surgical face mask: F-Y1-A (K202794) | Jiande Chaomei Daily Chemicals Co., Ltd. | 2021-12-13 |
| Medical Surgical Mask (K212867) | Nanchang Kanghua Health Materials Co., Ltd. | 2021-12-11 |
| MAF Guard (K211487) | Maf Clothing Pvt Ltd Unit-3 | 2021-12-08 |
| BAYLAB 3-Ply Surgical Mask (BEACON I) (K212302) | Baylab USA, LLC | 2021-12-07 |
| PMW01 Procedure Mask Level 1 (K211772) | Defender Safety, Inc. | 2021-12-06 |
| Surgical Face Mask (K212235) | Shanghai Yunqing Industrial Co., Ltd. | 2021-12-06 |
| Surgical Masks (K212807) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2021-12-03 |
| Puravita Medical Fold Flat Surgical Mask (K212740) | Puravita M, LLC | 2021-12-02 |
| Single-use Surgical Mask (K211773) | Taiwan Seafood and Fish Corporation | 2021-12-02 |
| Disposable Surgical Face Mask (K211696) | Anhui Cleanpro Pharmpack Co., Ltd. | 2021-11-30 |
| Medical surgical mask (K202842) | Henan Huibo Medical Co., Ltd. | 2021-11-26 |
| Surgical Mask (sterile) (K211295) | Nanjing 3h Medical Products Co., Ltd. | 2021-11-24 |
| 039 Surgical Face Mask (K211956) | Aok Tooling Limited | 2021-11-23 |
| Impertech Surgical Face Mask (K212046) | Impertech Industries , Ltd. | 2021-11-18 |
| Savvy Mask - Level 3 Surgical Face Mask (K213406) | Texas Medplast, LLC | 2021-11-18 |
| Disposable Surgical Mask (K210042) | Suzhou Letian Protective Products Co., Ltd. | 2021-11-17 |
| Surgical Mask (K212344) | Xiantao Dingcheng Non-Woven Product Co., Ltd. | 2021-11-16 |
| Spin Care Disposable Protective Mask Level 3 (K212109) | Spintech, LLC | 2021-11-14 |
| Surgical Face Mask (K212575) | Hubei Huanfu Plastic Products Co., Ltd. | 2021-11-14 |
| Surgical Face mask (K212264) | Nantong Taiweishi Medical Technology Co., Ltd. | 2021-11-13 |
| Medical Face Masks, Model Name:MY020003 (K211165) | Huizhou Jie Bai Purification Co., Ltd. | 2021-11-09 |
| Surgical Face Mask (K212526) | Suzhou Janee Medical Technology Co., Ltd. | 2021-11-09 |
| Disposable Medical Face Mask (K202676) | Zhejiang Senhong Medical&Instrument Co., Ltd. | 2021-11-05 |
| Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) (K212460) | Guangzhou Zhengkang Medical Equipment Co.,Ltd | 2021-11-05 |
| Medical Face Mask (K212471) | Haian Medigauze Co., Ltd. | 2021-11-04 |
| Disposable Medical Mask (K210222) | Guangdong Lide Medical Technology Co., Ltd. | 2021-11-02 |
| Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) (K212293) | Jiangmen Ningrui Medical Supplies Co., Ltd. | 2021-10-25 |
| Surgical Face Mask (K212368) | Anhui Tiankang Medical Technology Co., Ltd. | 2021-10-24 |
| Disposable Medical Surgical Mask (K210348) | Weihai Dishang Medical Technology Co., Ltd. | 2021-10-24 |
| Surgical 3D Mask (K203565) | Inno Lifecare | 2021-10-19 |
| Medical Protective Masks (K212205) | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 2021-10-14 |
| Disposable Surgical Mask (Model: YYKZ-01) (K210845) | Jiaxing Amazing Travel-Ware Co., Ltd. | 2021-10-12 |
| Single-Use Medical Face Mask (K210622) | Jiangxi Hongda Medical Equipment Group Co., Ltd. | 2021-10-08 |
| Medical Surgical Mask (K210813) | Sichuan Pharmaceutical., Inc. | 2021-10-08 |
| Private Stock Labs Surgical Face Mask (K211425) | J.K. Private Stock, Inc. | 2021-10-04 |
| Surgical Face Mask (K211899) | Hubei Yi-Ya Protective Products Co., Ltd. | 2021-10-04 |
| UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 (K210513) | Universal Incorporation | 2021-09-29 |
| Surgical Face Mask (Model: CM2006, CM2008, A88) (K210878) | Shenzhen Realtone Medical Appliance Co., Ltd. | 2021-09-28 |
| Disposable surgical mask (K211794) | Shanghai No.9 Knitting Mill Co., Ltd. | 2021-09-28 |
| Surgical Mask (K210908) | Sichuan Prius Biotechnology Co., Ltd. | 2021-09-26 |
| Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) (K211827) | Zhejiang Lanhine Medical Products, Ltd. | 2021-09-23 |
| Banyan USA Surgical Mask Level 3 (K211097) | Banyan USA, LLC | 2021-09-22 |
| 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) (K210772) | Vr Vertical, LLC Dba Xrgo | 2021-09-22 |
| Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) (K203418) | Ningbo Ouhan Medical Device Co., Ltd. | 2021-09-17 |
| WELLTRUST WT-III Mask with Flat Earloop (K211751) | Lonestar Meadows, LLC | 2021-09-17 |
| Disposable Medical Mask (K203112) | Yangzhou Runyi Arts & Crafts Co., Ltd. | 2021-09-16 |
| Wilson Tech Disposable Medical Face Mask (K210184) | Wilson Tech (International) Limited | 2021-09-14 |
| Disposable Medical Mask (K203455) | Fujian Kang Chen Daily Necessities Co., Ltd. | 2021-09-13 |
| Surgical face mask (K211296) | Sunsmed Protective Products , Ltd. | 2021-09-11 |
| Surgical Mask (K212451) | Remade USA, LLC | 2021-09-10 |
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