FXX
607 FDA 510(k) clearances · Product code
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| Record | Firm | Date |
|---|---|---|
| Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask (K211832) | Zhejiang Lanhine Medical Products, Ltd. | 2021-09-08 |
| Altor Safety 4-Ply Surgical Mask (Model:62232) (K211762) | Altor Safety, LLC | 2021-09-03 |
| Welspun Health Surgical Mask (K211536) | Welspun India Limited | 2021-09-01 |
| Surgical Mask (K211255) | Tianchang Kanghui Protective Products Co, Ltd. | 2021-08-28 |
| Surgical mask (K202746) | Ningbo Jingeao Electronics, Inc. | 2021-08-27 |
| Disposable Surgical Mask (non sterile) (K211451) | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 2021-08-25 |
| Disposable medical face mask (K202745) | Ningbo Jingeao Electronics, Inc. | 2021-08-23 |
| Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 (K211066) | Homtex, Inc. | 2021-08-19 |
| ECOMA Level 2 Disposable Surgical Mask with Ear Loops (K210698) | Xianning Eco Medical Articles Co., Ltd. | 2021-08-19 |
| WYZ Surgical Mask (K211576) | Wyz Medical Supplies, LLC | 2021-08-19 |
| Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask (K211462) | Xiantao S&J Protective Products Co., Ltd. | 2021-08-19 |
| CiRx (R) Surgical Mask (K210256) | Ningbo Shun YE Medical Company, Ltd. | 2021-08-19 |
| Surgical Face Mask (K211631) | Macheng Thimble Technology Investment Co., Ltd. | 2021-08-18 |
| Surgical mask (K211454) | Jiangsu Xingtong Biotechnology Group Co., Ltd. | 2021-08-18 |
| Disposable medical surgical mask (K212097) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2021-08-18 |
| Disposable Face Mask (K203152) | Chaozhou Cecilia Technology Co., Ltd. | 2021-08-11 |
| Surgical mask (K211552) | Shandong Shengquan New Materials Co., Ltd. | 2021-08-11 |
| Medical Face Mask (K211353) | Shenzhen Lyttop Healthcare Limited | 2021-08-11 |
| Disposable Surgical Face Mask (K210643) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-08-04 |
| Surgical Face Mask (K211897) | Zhejiang Hongyu Medicali Commodity Co., Ltd. | 2021-08-03 |
| Disposable Medical Mask (K203174) | Dong Guan Kinyet Metal Products Co., Ltd. | 2021-08-02 |
| MEO Med Disposable Medical Face Mask (K210870) | Fujian Meo Medical Technology Limited | 2021-07-30 |
| Disposable Surgical Face Mask (K210409) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-07-28 |
| Purism Disposable Surgical Mask (K210856) | Chuzhou Daddy'S Choice Science and Technology Co., Ltd. | 2021-07-28 |
| TAIJI Professional Series Level 3 Surgical Face Mask (K211861) | Taiji Medical Supplies, Inc. | 2021-07-28 |
| Surgical Mask (K211497) | Honeywell Safety Products | 2021-07-28 |
| MASC Surgical Mask (K211984) | Mid-America Safety Corp. | 2021-07-25 |
| Medical Face Mask (K211363) | Hubei Kangning Protective Products Co., Ltd. | 2021-07-24 |
| Altor Safety 3-Ply Surgical Mask (Model:62222) (K211249) | Altor Safety, LLC | 2021-07-23 |
| Single-use medical face mask (K210391) | Zhuhai Herald Datanetics Limited. | 2021-07-22 |
| Single-Use Surgical Mask Model FE2311B (K210970) | Byd Precison Manufacturer Co., Ltd. | 2021-07-21 |
| Surgical face mask (Model: Flat Ear Loop/CN102) (K203534) | Crown Name Disposable Hygiene Products Fty., Ltd. | 2021-07-21 |
| Velguard Surgical Face Mask (K210761) | Esstee Exports Health Care Division | 2021-07-16 |
| Disposable Procedural Ear-loop Face Mask (K211042) | Changzhou Dsb Medical Co., Ltd. | 2021-07-15 |
| Surgical Face Mask, Surgical Mask (K201844) | Lear Corporation | 2021-07-14 |
| Disposable Medical Face Mask (K210244) | Suzhou Bolisi Medical Technology Co., Ltd. | 2021-07-12 |
| Disposable Surgical Mask (K210267) | Xiamen Eagledon Pharmaceutical Co., Ltd. | 2021-07-08 |
| Medical surgical mask (K210380) | Shantou T&K Medical Equipment Factory Co.,Ltd | 2021-07-08 |
| Surgical Mask (K210524) | Changzhou Holymed Products Co., Ltd. | 2021-07-07 |
| Disposable Surgical Mask (K202954) | Xiamen Probtain Medical Techology Co., Ltd. | 2021-07-02 |
| Single-use Medical Face Mask (K203591) | Conod Medical Co., Limited | 2021-07-02 |
| Nordiwell Surprotect Face Mask (K210445) | Changzhou Combat Protective Equipment Co., Ltd. | 2021-06-29 |
| Disposable Surgical Mask (K210840) | Safeway Industry Healthcare. | 2021-06-22 |
| Disposable Medical Surgical Face Mask (K203200) | Guangdong Haiou Medical Apparatus Co., Ltd. | 2021-06-16 |
| Amerishield Surgical Mask (K211520) | Premiumestore, LLC | 2021-06-15 |
| Surgical Face Mask (K210518) | Shandong Haidike Medical Products Co., Ltd. | 2021-06-14 |
| Surgical Face Mask (K203732) | Zhuhai Gaoge Medical Technology Co., Ltd. | 2021-06-11 |
| Medical Face Mask (K202714) | Chongqing Chaoke Industry Development Co., Ltd. | 2021-06-11 |
| Disposable Surgical Mask (K203756) | Lucky Textile Industrial(Wuxi) Co., Ltd. | 2021-06-10 |
| Surgical Masks, Model:FE-1 (K210767) | Hunan Triplex Precision Medical Devices Co., Ltd. | 2021-06-10 |
| Surgical Face Mask (K210015) | Sample King Manufacturing, Ltd. | 2021-06-10 |
| Medical Face Mask (K211062) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2021-06-08 |
| Disposable Surgical Mask (K202126) | Shenzhen Peninsula Medical Co., Ltd. | 2021-06-08 |
| Disposable Surgical Mask (K210372) | Dongguan Shin YI Healthcare Products Factory | 2021-06-07 |
| Disposable Medical Mask (K210641) | Tuosheng Protective Products (Ningbo) Co., Ltd. | 2021-06-07 |
| Surgical Face Mask (Ear loops and Tie-on) (K210433) | Wuhan Dymex Healthcare Co., Ltd. | 2021-06-07 |
| Disposable Surgical Mask (K202580) | Qingdao Likangyuan Medical Device Co., Ltd. | 2021-06-07 |
| Surgical face mask (K203704) | Juntech(Jiaxing)Healthcare Materials Co,.Ltd | 2021-06-04 |
| Disposable medical mask (K203388) | Everwin Toys (Dongguan)., Ltd. | 2021-06-04 |
| Allmed Surgical Face Masks (Ear loops) (K202128) | Allmed Medical Products Co., Ltd. | 2021-06-03 |
| Surgical Face Mask (K203190) | Rfx+Care Manufactoring Co., Ltd. | 2021-06-02 |
| Disposable Medical mask (K210150) | Hubei Wanli Protective Products Co., Ltd. | 2021-06-02 |
| Disposable Surgical Face Mask (K210429) | Jiangxi Heying Pharmaceutical Co., Ltd. | 2021-06-02 |
| ASM-301 Level 3 Surgical Mask (K211440) | American Surgical Mask Company, LLC | 2021-06-02 |
| AirMax Procedure Mask (K211275) | Premiumestore, LLC | 2021-05-25 |
| Procedure Mask, Surgical Mask (K202899) | Kenpax International Limited | 2021-05-20 |
| Ear-Friendly Mask (K211105) | Ray Co., Ltd. | 2021-05-17 |
| Disposable Medical mask (K210302) | Anhui Jbh Medical Apparatus Co., Ltd. | 2021-05-14 |
| United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask (K202697) | United Sewing Automation, Inc. | 2021-05-13 |
| Disposable Face Mask (K210815) | Biobase Scientific (Shandong) Co., Ltd. | 2021-05-13 |
| SURGICAL MASK, Model Name:C015 (K210218) | Qingdao Hainuo Biological Engineering Co., Ltd. | 2021-05-07 |
| Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 (K210705) | Defender Safety, Inc. | 2021-05-06 |
| 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3 (K202598) | 3A Medical Products Co., Ltd. | 2021-05-06 |
| Surgical Mask (K210304) | Jin Pin Electrical Co., Ltd. Zhuhai S.E.Z. | 2021-05-04 |
| M1 Surgical Face Mask (K202457) | CHISON Medical Technologies Co., Ltd. | 2021-04-29 |
| Medical Mask (K210020) | Zhende Medical Co., Ltd. | 2021-04-28 |
| Surgical Mask (K202647) | Ningbo Green Textile Co., Ltd. | 2021-04-26 |
| Disposable Surgical Face Mask (K202387) | Guangdong Bida Medical Technology Co., Ltd. | 2021-04-23 |
| Face Mask (K210007) | Jinhua Jingdi Medical Supplies Co., Ltd. | 2021-04-23 |
| Naton Disposable Surgical Face Mask (K201853) | Naton Biotechnology (Beijing) Co., Ltd. | 2021-04-23 |
| Medical Surgical Mask (K210030) | Tianjin Aoshang Outdoor Equipment Co., Ltd. | 2021-04-23 |
| Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs (K202607) | String King Lacrosse, LLC | 2021-04-23 |
| Disposable Medical Face Mask (K203646) | Guangzhou Mei YI Kang Medical Technology Co., Ltd. | 2021-04-22 |
| Disposable medical surgical mask (K202759) | Chongqing Coe Display Technology Co., Ltd. | 2021-04-21 |
| GD Disposable Medical Face Mask (K201718) | Jiangsu Guangda Medical Material Group Co., Ltd. | 2021-04-15 |
| DEFEND Ear-loop Face Masks (K201127) | Young Dental Manufacturing Co. 1, LLC | 2021-04-14 |
| Medical Surgical Mask (Non-sterile) (K202761) | Guangdong Goodfeeling Hygiene Material Tec Co., Ltd. | 2021-04-11 |
| Surgical Mask (K203012) | Customfab, Inc. | 2021-04-11 |
| Disposable Medical Mask (K210018) | Diasia Biomedical Technology Co., Ltd. | 2021-04-11 |
| Disposable Medical Face Mask-Model FM-04 (K202513) | Shenzhen Jinko Industrial Co., Ltd. | 2021-04-09 |
| Disposable Surgical Face Mask (K203801) | Anhui Jiabao Protective Equipments Co., Ltd. | 2021-04-06 |
| Disposable Medical Mask (K202655) | Dongguan Runlin Medical Supplies Technology Co., Ltd. | 2021-04-05 |
| Surgical Face Mask (K210023) | Guangdong Winsun Personal Care Products Co.,Ltd | 2021-04-02 |
| Surgical Mask-Models CR02-2, CR02 (K202424) | Foshan Xinbao Technology Co., Ltd. | 2021-03-31 |
| Secure Wear USA Surgical Face Mask (K203101) | Secured Ortho Manufacturing of America, LLC | 2021-03-31 |
| ivi N3003 Surgical face Mask, ivi N6006 Surgical mask (K201896) | Iob Medical, Inc. | 2021-03-30 |
| Surgical Face Masks (K202708) | Intco Medical(Hk) Co., Ltd. | 2021-03-30 |
| Surgical Mask (K202191) | Wuhan Zonsen Medical Products Co., Ltd. | 2021-03-29 |
| Disposable Face Mask (K202905) | Jiangsu Excellence Medical Supplies Co., Ltd. | 2021-03-26 |
| Disposable Surgical Face Mask (K203685) | Xiantao Zhongyi Safety & Protection Products Co., Ltd. | 2021-03-26 |
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