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 3 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211832 | Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask | Zhejiang Lanhine Medical Products, Ltd. | 2021-09-08 | Traditional | PDF ↗ |
| K211762 | Altor Safety 4-Ply Surgical Mask (Model:62232) | Altor Safety, LLC | 2021-09-03 | Traditional | PDF ↗ |
| K211536 | Welspun Health Surgical Mask | Welspun India Limited | 2021-09-01 | Traditional | PDF ↗ |
| K211255 | Surgical Mask | Tianchang Kanghui Protective Products Co, Ltd. | 2021-08-28 | Traditional | PDF ↗ |
| K202746 | Surgical mask | Ningbo Jingeao Electronics, Inc. | 2021-08-27 | Traditional | PDF ↗ |
| K211451 | Disposable Surgical Mask (non sterile) | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 2021-08-25 | Traditional | PDF ↗ |
| K202745 | Disposable medical face mask | Ningbo Jingeao Electronics, Inc. | 2021-08-23 | Traditional | PDF ↗ |
| K211066 | Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 | Homtex, Inc. | 2021-08-19 | Abbreviated | PDF ↗ |
| K210698 | ECOMA Level 2 Disposable Surgical Mask with Ear Loops | Xianning Eco Medical Articles Co., Ltd. | 2021-08-19 | Traditional | PDF ↗ |
| K211576 | WYZ Surgical Mask | Wyz Medical Supplies, LLC | 2021-08-19 | Traditional | PDF ↗ |
| K210256 | CiRx (R) Surgical Mask | Ningbo Shun YE Medical Company, Ltd. | 2021-08-19 | Traditional | PDF ↗ |
| K211462 | Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask | Xiantao S&J Protective Products Co., Ltd. | 2021-08-19 | Traditional | PDF ↗ |
| K212097 | Disposable medical surgical mask | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2021-08-18 | Traditional | PDF ↗ |
| K211454 | Surgical mask | Jiangsu Xingtong Biotechnology Group Co., Ltd. | 2021-08-18 | Traditional | PDF ↗ |
| K211631 | Surgical Face Mask | Macheng Thimble Technology Investment Co., Ltd. | 2021-08-18 | Traditional | PDF ↗ |
| K203152 | Disposable Face Mask | Chaozhou Cecilia Technology Co., Ltd. | 2021-08-11 | Traditional | PDF ↗ |
| K211353 | Medical Face Mask | Shenzhen Lyttop Healthcare Limited | 2021-08-11 | Traditional | PDF ↗ |
| K211552 | Surgical mask | Shandong Shengquan New Materials Co., Ltd. | 2021-08-11 | Traditional | PDF ↗ |
| K210643 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-08-04 | Traditional | PDF ↗ |
| K211897 | Surgical Face Mask | Zhejiang Hongyu Medicali Commodity Co., Ltd. | 2021-08-03 | Traditional | PDF ↗ |
| K203174 | Disposable Medical Mask | Dong Guan Kinyet Metal Products Co., Ltd. | 2021-08-02 | Traditional | PDF ↗ |
| K210870 | MEO Med Disposable Medical Face Mask | Fujian Meo Medical Technology Limited | 2021-07-30 | Traditional | PDF ↗ |
| K211497 | Surgical Mask | Honeywell Safety Products | 2021-07-28 | Traditional | PDF ↗ |
| K210856 | Purism Disposable Surgical Mask | Chuzhou Daddy'S Choice Science and Technology Co., Ltd. | 2021-07-28 | Traditional | PDF ↗ |
| K211861 | TAIJI Professional Series Level 3 Surgical Face Mask | Taiji Medical Supplies, Inc. | 2021-07-28 | Abbreviated | PDF ↗ |
| K210409 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-07-28 | Traditional | PDF ↗ |
| K211984 | MASC Surgical Mask | Mid-America Safety Corp. | 2021-07-25 | Traditional | PDF ↗ |
| K211363 | Medical Face Mask | Hubei Kangning Protective Products Co., Ltd. | 2021-07-24 | Traditional | PDF ↗ |
| K211249 | Altor Safety 3-Ply Surgical Mask (Model:62222) | Altor Safety, LLC | 2021-07-23 | Traditional | PDF ↗ |
| K210391 | Single-use medical face mask | Zhuhai Herald Datanetics Limited. | 2021-07-22 | Traditional | PDF ↗ |
| K203534 | Surgical face mask (Model: Flat Ear Loop/CN102) | Crown Name Disposable Hygiene Products Fty., Ltd. | 2021-07-21 | Traditional | PDF ↗ |
| K210970 | Single-Use Surgical Mask Model FE2311B | Byd Precison Manufacturer Co., Ltd. | 2021-07-21 | Traditional | PDF ↗ |
| K210761 | Velguard Surgical Face Mask | Esstee Exports Health Care Division | 2021-07-16 | Traditional | PDF ↗ |
| K211042 | Disposable Procedural Ear-loop Face Mask | Changzhou Dsb Medical Co., Ltd. | 2021-07-15 | Traditional | PDF ↗ |
| K201844 | Surgical Face Mask, Surgical Mask | Lear Corporation | 2021-07-14 | Abbreviated | PDF ↗ |
| K210244 | Disposable Medical Face Mask | Suzhou Bolisi Medical Technology Co., Ltd. | 2021-07-12 | Traditional | PDF ↗ |
| K210267 | Disposable Surgical Mask | Xiamen Eagledon Pharmaceutical Co., Ltd. | 2021-07-08 | Traditional | PDF ↗ |
| K210380 | Medical surgical mask | Shantou T&K Medical Equipment Factory Co.,Ltd | 2021-07-08 | Traditional | PDF ↗ |
| K210524 | Surgical Mask | Changzhou Holymed Products Co., Ltd. | 2021-07-07 | Traditional | PDF ↗ |
| K203591 | Single-use Medical Face Mask | Conod Medical Co., Limited | 2021-07-02 | Traditional | PDF ↗ |
| K202954 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co., Ltd. | 2021-07-02 | Traditional | PDF ↗ |
| K210445 | Nordiwell Surprotect Face Mask | Changzhou Combat Protective Equipment Co., Ltd. | 2021-06-29 | Traditional | PDF ↗ |
| K210840 | Disposable Surgical Mask | Safeway Industry Healthcare. | 2021-06-22 | Traditional | PDF ↗ |
| K203200 | Disposable Medical Surgical Face Mask | Guangdong Haiou Medical Apparatus Co., Ltd. | 2021-06-16 | Traditional | PDF ↗ |
| K211520 | Amerishield Surgical Mask | Premiumestore, LLC | 2021-06-15 | Traditional | PDF ↗ |
| K210518 | Surgical Face Mask | Shandong Haidike Medical Products Co., Ltd. | 2021-06-14 | Traditional | PDF ↗ |
| K203732 | Surgical Face Mask | Zhuhai Gaoge Medical Technology Co., Ltd. | 2021-06-11 | Traditional | PDF ↗ |
| K202714 | Medical Face Mask | Chongqing Chaoke Industry Development Co., Ltd. | 2021-06-11 | Traditional | PDF ↗ |
| K210767 | Surgical Masks, Model:FE-1 | Hunan Triplex Precision Medical Devices Co., Ltd. | 2021-06-10 | Traditional | PDF ↗ |
| K203756 | Disposable Surgical Mask | Lucky Textile Industrial(Wuxi) Co., Ltd. | 2021-06-10 | Traditional | PDF ↗ |
| K210015 | Surgical Face Mask | Sample King Manufacturing, Ltd. | 2021-06-10 | Traditional | PDF ↗ |
| K211062 | Medical Face Mask | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2021-06-08 | Traditional | PDF ↗ |
| K202126 | Disposable Surgical Mask | Shenzhen Peninsula Medical Co., Ltd. | 2021-06-08 | Traditional | PDF ↗ |
| K202580 | Disposable Surgical Mask | Qingdao Likangyuan Medical Device Co., Ltd. | 2021-06-07 | Traditional | PDF ↗ |
| K210433 | Surgical Face Mask (Ear loops and Tie-on) | Wuhan Dymex Healthcare Co., Ltd. | 2021-06-07 | Traditional | PDF ↗ |
| K210641 | Disposable Medical Mask | Tuosheng Protective Products (Ningbo) Co., Ltd. | 2021-06-07 | Traditional | PDF ↗ |
| K210372 | Disposable Surgical Mask | Dongguan Shin YI Healthcare Products Factory | 2021-06-07 | Traditional | PDF ↗ |
| K203704 | Surgical face mask | Juntech(Jiaxing)Healthcare Materials Co,.Ltd | 2021-06-04 | Traditional | PDF ↗ |
| K203388 | Disposable medical mask | Everwin Toys (Dongguan)., Ltd. | 2021-06-04 | Traditional | PDF ↗ |
| K202128 | Allmed Surgical Face Masks (Ear loops) | Allmed Medical Products Co., Ltd. | 2021-06-03 | Traditional | PDF ↗ |
| K211440 | ASM-301 Level 3 Surgical Mask | American Surgical Mask Company, LLC | 2021-06-02 | Traditional | PDF ↗ |
| K210429 | Disposable Surgical Face Mask | Jiangxi Heying Pharmaceutical Co., Ltd. | 2021-06-02 | Traditional | PDF ↗ |
| K203190 | Surgical Face Mask | Rfx+Care Manufactoring Co., Ltd. | 2021-06-02 | Traditional | PDF ↗ |
| K210150 | Disposable Medical mask | Hubei Wanli Protective Products Co., Ltd. | 2021-06-02 | Traditional | PDF ↗ |
| K211275 | AirMax Procedure Mask | Premiumestore, LLC | 2021-05-25 | Traditional | PDF ↗ |
| K202899 | Procedure Mask, Surgical Mask | Kenpax International Limited | 2021-05-20 | Traditional | PDF ↗ |
| K211105 | Ear-Friendly Mask | Ray Co., Ltd. | 2021-05-17 | Traditional | PDF ↗ |
| K210302 | Disposable Medical mask | Anhui Jbh Medical Apparatus Co., Ltd. | 2021-05-14 | Traditional | PDF ↗ |
| K202697 | United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask | United Sewing Automation, Inc. | 2021-05-13 | Abbreviated | PDF ↗ |
| K210815 | Disposable Face Mask | Biobase Scientific (Shandong) Co., Ltd. | 2021-05-13 | Traditional | PDF ↗ |
| K210218 | SURGICAL MASK, Model Name:C015 | Qingdao Hainuo Biological Engineering Co., Ltd. | 2021-05-07 | Traditional | PDF ↗ |
| K210705 | Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 | Defender Safety, Inc. | 2021-05-06 | Abbreviated | PDF ↗ |
| K202598 | 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 | 3A Medical Products Co., Ltd. | 2021-05-06 | Traditional | PDF ↗ |
| K210304 | Surgical Mask | Jin Pin Electrical Co., Ltd. Zhuhai S.E.Z. | 2021-05-04 | Traditional | PDF ↗ |
| K202457 | M1 Surgical Face Mask | CHISON Medical Technologies Co., Ltd. | 2021-04-29 | Traditional | PDF ↗ |
| K210020 | Medical Mask | Zhende Medical Co., Ltd. | 2021-04-28 | Traditional | PDF ↗ |
| K202647 | Surgical Mask | Ningbo Green Textile Co., Ltd. | 2021-04-26 | Traditional | PDF ↗ |
| K202607 | 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 | String King Lacrosse, LLC | 2021-04-23 | Traditional | PDF ↗ |
| K202387 | Disposable Surgical Face Mask | Guangdong Bida Medical Technology Co., Ltd. | 2021-04-23 | Traditional | PDF ↗ |
| K210007 | Face Mask | Jinhua Jingdi Medical Supplies Co., Ltd. | 2021-04-23 | Traditional | PDF ↗ |
| K201853 | Naton Disposable Surgical Face Mask | Naton Biotechnology (Beijing) Co., Ltd. | 2021-04-23 | Traditional | PDF ↗ |
| K210030 | Medical Surgical Mask | Tianjin Aoshang Outdoor Equipment Co., Ltd. | 2021-04-23 | Traditional | PDF ↗ |
| K203646 | Disposable Medical Face Mask | Guangzhou Mei YI Kang Medical Technology Co., Ltd. | 2021-04-22 | Traditional | PDF ↗ |
| K202759 | Disposable medical surgical mask | Chongqing Coe Display Technology Co., Ltd. | 2021-04-21 | Traditional | PDF ↗ |
| K201718 | GD Disposable Medical Face Mask | Jiangsu Guangda Medical Material Group Co., Ltd. | 2021-04-15 | Traditional | PDF ↗ |
| K201127 | DEFEND Ear-loop Face Masks | Young Dental Manufacturing Co. 1, LLC | 2021-04-14 | Abbreviated | PDF ↗ |
| K210018 | Disposable Medical Mask | Diasia Biomedical Technology Co., Ltd. | 2021-04-11 | Traditional | PDF ↗ |
| K203012 | Surgical Mask | Customfab, Inc. | 2021-04-11 | Abbreviated | PDF ↗ |
| K202761 | Medical Surgical Mask (Non-sterile) | Guangdong Goodfeeling Hygiene Material Tec Co., Ltd. | 2021-04-11 | Traditional | PDF ↗ |
| K202513 | Disposable Medical Face Mask-Model FM-04 | Shenzhen Jinko Industrial Co., Ltd. | 2021-04-09 | Traditional | PDF ↗ |
| K203801 | Disposable Surgical Face Mask | Anhui Jiabao Protective Equipments Co., Ltd. | 2021-04-06 | Traditional | PDF ↗ |
| K202655 | Disposable Medical Mask | Dongguan Runlin Medical Supplies Technology Co., Ltd. | 2021-04-05 | Traditional | PDF ↗ |
| K210023 | Surgical Face Mask | Guangdong Winsun Personal Care Products Co.,Ltd | 2021-04-02 | Traditional | PDF ↗ |
| K203101 | Secure Wear USA Surgical Face Mask | Secured Ortho Manufacturing of America, LLC | 2021-03-31 | Abbreviated | PDF ↗ |
| K202424 | Surgical Mask-Models CR02-2, CR02 | Foshan Xinbao Technology Co., Ltd. | 2021-03-31 | Traditional | PDF ↗ |
| K202708 | Surgical Face Masks | Intco Medical(Hk) Co., Ltd. | 2021-03-30 | Traditional | PDF ↗ |
| K201896 | ivi N3003 Surgical face Mask, ivi N6006 Surgical mask | Iob Medical, Inc. | 2021-03-30 | Traditional | PDF ↗ |
| K202191 | Surgical Mask | Wuhan Zonsen Medical Products Co., Ltd. | 2021-03-29 | Traditional | PDF ↗ |
| K203685 | Disposable Surgical Face Mask | Xiantao Zhongyi Safety & Protection Products Co., Ltd. | 2021-03-26 | Traditional | PDF ↗ |
| K202905 | Disposable Face Mask | Jiangsu Excellence Medical Supplies Co., Ltd. | 2021-03-26 | Traditional | PDF ↗ |
Product code FXX · Class II · General, Plastic Surgery. Data: openFDA.