Mask, Surgical
FDA product code FXX · Class II (moderate risk) · 21 CFR 878.4040 · General, Plastic Surgery
607510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Tecnol New Jersey Wound Care, Inc. 11
- Owens & Minor (O&M) Halyard, Inc. 8
- Protectaide, Inc. 7
- Anago, Inc. 7
- Guangdong Kingfa Sci. & Tech.Co., Ltd. 6
- 3M Company 6
- Tecnol Medical Products, Inc. 5
- Primed Medical Products, Inc. 4
- Kimberly-Clark Corp. 4
- Louis M. Gerson Co., Inc. 4
- Dukal Corp. 4
- White Knight Healthcare 4
- Creative Contract (M) Sdn Bhd 3
- Dispomed, Inc. 3
- Bfd, Inc. 3
- Prestige Ameritech 3
- Johnson & Johnson Medical, Inc. 3
- Abco Dealers, Inc. 3
- Crosstex International 3
- Carl Parker Associates, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…FXX · Traditional | O&M Halyard, Inc. | 03/18/2026SE |
| K252534 | Surgical Face Mask (Ear mount)FXX · Traditional | Zhejiang Hangkang Medical Equipment Co., Ltd. | 03/03/2026SE |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)FXX · Special | Efofex, Inc. | 02/19/2026SE |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900)FXX · Traditional | Beatles Medical Supplies (Xiantao) Co., Ltd. | 01/12/2026SE |
| K252650 | Disposable Medical Face MaskFXX · Traditional | Makrite Industries, Inc. | 01/05/2026SE |
| K243342 | KP Protective Face MaskFXX · Traditional | Kp Trading Co., Ltd. | 12/22/2025SE |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsFXX · Traditional | O&M Halyard, Inc. | 12/11/2025SE |
| K252964 | PRIMED Surgical and Procedure MasksFXX · Traditional | Primed Medical Products, Inc. | 11/04/2025SE |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…FXX · Traditional | Vitacore Industries, Inc. | 09/17/2025SE |
| K250082 | Procedure mask/Surgical mask/Face maskFXX · Traditional | Winner Medical Co., Ltd. | 06/18/2025SE |
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)…FXX · Abbreviated | Owens & Minor (O&M) Halyard, Inc. | 05/30/2025SE |
| K242502 | Aurelia Surgical Mask ASTM Level-3 (2130)FXX · Traditional | Supermax Healthcare Canada Supermax Medical | 11/12/2024SE |
| K240916 | Surgical Face Mask (Tie on/ Ear loops)FXX · Traditional | Xiantao Daoqi Plastic Co., Ltd. | 10/18/2024SE |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure MasksFXX · Traditional | Primed Medical Products, Inc. | 08/26/2024SE |
| K233723 | Medical surgical maskFXX · Traditional | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 07/29/2024SE |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White…FXX · Traditional | Owens & Minor (O&M) Halyard, Inc. | 07/02/2024SE |
| K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender…FXX · Traditional | Owens & Minor (O&M) Halyard, Inc. | 07/01/2024SE |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)…FXX · Traditional | Owens & Minor (O&M) Halyard, Inc. | 06/21/2024SE |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask…FXX · Traditional | Owens & Minor (O&M) Halyard, Inc. | 06/14/2024SE |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867)…FXX · Traditional | Owens & Minor (O&M) Halyard, Inc. | 06/07/2024SE |
| K232968 | Grande Medical Masks, Model SF-600FXX · Traditional | Golden Grande Corp. | 06/06/2024SE |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)FXX · Traditional | Owens & Minor (O&M) Halyard, Inc. | 06/04/2024SE |
| K240258 | Disposable Medical Face Mask (M643BE)FXX · Traditional | Makrite Industries, Inc. | 04/18/2024SE |
| K232112 | R&G Surgical MaskFXX · Traditional | R&G Seguridad E Higiene Industrial S.A.C. | 04/02/2024SE |
| K231719 | Medical Surgical MaskFXX · Traditional | Azur Medical Company, Inc. | 03/19/2024SE |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining…FXX · Traditional | Owens & Minor (O&M) Halyard, Inc. | 01/08/2024SE |
| K232797 | HygenixFXX · Traditional | Shenzhen Hygenix Industrial Co., Ltd. | 12/11/2023SE |
| K231005 | Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2FXX · Traditional | Supermax Healthcare Canada-Supermax Medical | 12/05/2023SE |
| K231155 | Biodegradable Medical surgical maskFXX · Traditional | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 11/07/2023SE |
| K232359 | Surgical face maskFXX · Traditional | Kingstar Medical (Xianning) Co., Ltd. | 10/02/2023SE |
| K230380 | Surgical Face Masks, Model: EFMDS-L50Pn BLUFXX · Traditional | Iris USA | 08/03/2023SE |
| K231618 | 3 Layer Surgical Mask (134252531)FXX · Traditional | Original Mattress Factory, Inc. | 07/28/2023SE |
| K230395 | Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)FXX · Traditional | Durio Ppe Sdn Bhd | 07/17/2023SE |
| K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health…FXX · Abbreviated | Cardinalhealth | 07/03/2023SE |
| K230617 | Surgical Face Mask (L 175*95mm)FXX · Traditional | Henan Chaoya Medical Equipment Co., Ltd. | 06/01/2023SE |
| K222545 | Disposable Medical MaskFXX · Traditional | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 05/19/2023SE |
| K223823 | Disposable Surgical Face MaskFXX · Traditional | Efofex, Inc. | 03/27/2023SE |
| K223236 | Medline Surgical Face Mask and Medline Procedural Face MaskFXX · Traditional | Medline Industries, LP | 03/24/2023SE |
| K221352 | Surgical Face MaskFXX · Traditional | Wuhan Huashida Protective Products Co., Ltd. | 03/13/2023SE |
| K221209 | PRECISION ECO Compostable / Plant Based Procedural Mask with EarloopsFXX · Traditional | Padm Medical, Inc. | 03/08/2023SE |
| K230383 | Savvy Surgical Mask - Level 3FXX · Traditional | Alg Health, LLC | 03/06/2023SE |
| K223232 | Procedure mask/Surgical mask/Face maskFXX · Traditional | Winner Medical Co., Ltd. | 03/06/2023SE |
| K230093 | Disposable 4 Layers Surgical Face MaskFXX · Traditional | Social Medical Supply, LLC | 03/02/2023SE |
| K223686 | Medical Protective MasksFXX · Traditional | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 02/07/2023SE |
| K221682 | Ideal Med Pro 3-Ply Disposable Face MaskFXX · Traditional | Jsn Holdings, LLC | 01/13/2023SE |
| K203380 | Disposable Surgical Face MaskFXX · Traditional | Shandong Pop Jeans Intelligent Manufacturing… | 01/06/2023SE |
| K222483 | Surgical Face MaskFXX · Traditional | Hubei Woozon Healthcare Co., Ltd. | 01/04/2023SE |
| K222809 | Medical Disposable Face MasksFXX · Traditional | Anqing Mayfield Medical Limited | 01/03/2023SE |
| K213601 | Surgical MaskFXX · Traditional | Wuhan Zonsen Medical Products Co., Ltd. | 12/16/2022SE |
| K220520 | PM Excellence SEQUR 100 Surgical Face MaskFXX · Traditional | Pm Excellence, LLC | 12/15/2022SE |
| K222651 | Surgical Face MaskFXX · Traditional | Xiantao Sanda Industrial Co., Ltd. | 12/13/2022SE |
| K223045 | 3-Ply Disposable Medical MaskFXX · Traditional | Wealth Lead Industrial Limited | 12/07/2022SE |
| K223055 | Disposable Medical Face MaskFXX · Traditional | Xiantao Zhuobo Industrial Co., Ltd. | 12/05/2022SE |
| K223068 | Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)FXX · Traditional | Guangdong Golden Leaves Technology Development… | 11/23/2022SE |
| K223003 | Banded Face MaskFXX · Special | Hubei Medlink Healthcare Co., Ltd. | 11/18/2022SE |
| K220302 | Disposable surgical face maskFXX · Abbreviated | Shandong Aida Medical Products Co., Ltd. | 11/16/2022SE |
| K203528 | KNH Surgical Face MaskFXX · Traditional | Knh Surgical Face Mask | 11/16/2022SE |
| K222749 | High Fluid-Resistant Surgical and Procedure MaskFXX · Traditional | AmericaS Supply Chains | 11/14/2022SE |
| K222529 | Surgical Face MaskFXX · Traditional | Xiantao Rayxin Medical Products Co., Ltd. | 11/14/2022SE |
| K222551 | Humask Pro Vision, Humask Pro Vision 3000FXX · Abbreviated | Entreprise Premont, Inc. | 11/10/2022SE |
| K222697 | Disposable Medical Face Mask (DF3-001)FXX · Traditional | Wellmed Dental Medical Supply Co., Ltd. | 11/04/2022SE |
| K223270 | POSE Health Care Surgical MaskFXX · Traditional | America'S Supply Chains | 11/01/2022SE |
| K212649 | Disposable Surgical Face MaskFXX · Traditional | Lyncmed Medical Technology (Beijing) Co., Ltd. | 10/25/2022SE |
| K222335 | Surgical MaskFXX · Traditional | Luoyang Sunmed Devices Co., Ltd. | 10/11/2022SE |
| K222266 | Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)FXX · Traditional | Jingzhou Haixin Green Cross Medical Products… | 09/26/2022SE |
| K222204 | Medical Surgical MaskFXX · Traditional | Guangzhou Zhengkang Medical Equipment Co.,Ltd | 09/23/2022SE |
| K221976 | Surgical Face Mask (Non-sterile)FXX · Traditional | Xiantao Junhui Plastic Products Co., Ltd. | 09/20/2022SE |
| K221534 | Surgical Face Masks (Ear Loops And Tie-On)FXX · Traditional | San-M Package Co., Ltd. | 09/16/2022SE |
| K212926 | AllureTM Surgical MaskFXX · Traditional | Allure Gift Wraps Private Limited | 09/16/2022SE |
| K214035 | LAITEST Medical Face MaskFXX · Traditional | R&R Medical Corporation, Ltd. | 09/13/2022SE |
| K220944 | PointCore Surgical MaskFXX · Traditional | Pointcore, Inc. | 09/09/2022SE |
| K222426 | Perfetta Moderate Medical Face MaskFXX · Traditional | Phu Bao Group Company Limited | 09/02/2022SE |
| K221957 | Savewo ClassicMASKFXX · Traditional | Savewo Limited | 09/02/2022SE |
| K221038 | Disposable Medical MasksFXX · Traditional | Hantech Medical Device Co., Ltd. | 09/01/2022SE |
| K220067 | Medical Surgery Mask, Model:2626-7FXX · Traditional | Dongguan Missadola Technology Co., Ltd. | 08/30/2022SE |
| K211771 | The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical…FXX · Traditional | The Good Corporation | 08/24/2022SE |
| K203078 | CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AWFXX · Abbreviated | Huizhou Tianchang Industrial Co., Ltd. | 08/19/2022SE |
| K221838 | Surgical Face Mask (HNFM0103)FXX · Traditional | Shanghai Hua EN Industrial Co, Ltd. | 08/17/2022SE |
| K212273 | Cross Protection ResQ300 Plus Surgical Face MaskFXX · Traditional | Cross Protection (M) Sdn Bhd | 08/17/2022SE |
| K220876 | AOK 95A Medical Mask (20200049)FXX · Traditional | Aok Tooling Limited | 07/27/2022SE |
| K221409 | Paneffort 3-ply Surgical and Procedural MasksFXX · Traditional | Paneffort, LLC | 07/25/2022SE |
| K221196 | Disposable Medical Face Mask (ear loop)FXX · Traditional | Xiantao Topmed Nonwoven Protective Products Co.… | 07/22/2022SE |
| K220777 | Surgical face maskFXX · Traditional | Hubei Qianjiang Kingphar Medical Material Co.… | 07/19/2022SE |
| K221173 | Surgical Mask (Model: 0868F, 0866F)FXX · Traditional | Jiangxi Sanhao Medical Instruments Co.,Ltd | 07/06/2022SE |
| K220378 | Sparta 3-Ply Surgical Disposable Face MaskFXX · Traditional | Sparta East, LLC | 06/30/2022SE |
| K221273 | Medical Face Mask (M001)FXX · Traditional | Xingyu Medical Tech Co., Ltd. | 06/28/2022SE |
| K221272 | Medical Face MaskFXX · Traditional | Shandong Xingyu Gloves Co., Ltd. | 06/28/2022SE |
| K220670 | MagnumFXX · Traditional | Magnum Health and Safety Pvt, Ltd. | 06/28/2022SE |
| K220377 | Procedure MaskFXX · Traditional | Little Rapids Corporation | 06/24/2022SE |
| K220550 | Disposable Surgical Face Mask (M663BE, M663BT)FXX · Traditional | Makrite Industries, Inc. | 06/14/2022SE |
| K221222 | Surgical Face Mask (HNFM0304)FXX · Traditional | Shanghai Hua EN Industrial Co, Ltd. | 06/06/2022SE |
| K220597 | Disposable Surgical Face Mask (FM-34EE,FM-44EE)FXX · Traditional | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 05/26/2022SE |
| K220191 | Disposable Face MaskFXX · Traditional | Jiujiang Taixin Technology Co., Ltd. | 05/24/2022SE |
| K220532 | Disposable surgical maskFXX · Traditional | Xiamen Blue Star Enterprise Co., Ltd. | 05/23/2022SE |
| K221134 | Procedure Mask with Ear Loops and Surgical Mask with TiesFXX · Traditional | Safesource Direct, LLC | 05/19/2022SE |
| K220824 | Medical Surgical Mask (Planar type)FXX · Traditional | Hunan Chopard Medical Devices Co., Ltd. | 05/19/2022SE |
| K220194 | Procedure mask/Surgical mask/Face maskFXX · Traditional | Winner Medical Co., Ltd. | 05/17/2022SE |
| K220749 | Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOPFXX · Traditional | Unimax Medical Products Co., Ltd. | 05/13/2022SE |
| K213001 | Procedure Mask, Surgical MaskFXX · Traditional | A Plus International, Inc. | 05/11/2022SE |
| K220487 | Disposable Medical Face MaskFXX · Traditional | Hubei Mediunion Medical Products Co., Ltd. | 04/26/2022SE |
| K220512 | Disposable Surgical Face Mask (M01, M02)FXX · Traditional | Fomed Industries, Inc. | 04/25/2022SE |
| K212203 | Dong Hai Xiang Surgical MaskFXX · Traditional | Taizhou Donghaixiang Protective Equipment Co.… | 04/07/2022SE |
| K210860 | Comfort Guard Mask, level 1, Comfort Guard Mask, level 3FXX · Traditional | Gri-Alleset, Inc. | 04/07/2022SE |
| K214085 | Disposable Medical MaskFXX · Traditional | Hubei Wanli Protective Products Co., Ltd. | 04/06/2022SE |
| K213450 | Medical surgical mask (Black mask, Level 1 and Level 3)FXX · Traditional | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 04/05/2022SE |
| K213736 | Medical Face MaskFXX · Traditional | Hangzhou Runheng Medical Co., Ltd. | 03/31/2022SE |
| K210422 | INTAI Surgical Mask (non-sterile)FXX · Traditional | Intai Technology Corp. | 03/30/2022SE |
| K220637 | 3 Ply Medical Grade Single Use Procedural Disposable Face MaskFXX · Traditional | Kdi Med Supply | 03/25/2022SE |
| K220187 | Medical Surgical Mask (Model: JM92, JM92B)FXX · Traditional | Guangdong Jia Mei Biological Technology Co.Ltd | 03/25/2022SE |
| K202903 | Surgical Face MaskFXX · Traditional | Rizhao Sanqi Medical & Health Articles Co., Ltd. | 03/24/2022SE |
| K212726 | Disposable Medical Surgical MaskFXX · Traditional | Hubei Huaqiang High-Tech Co., Ltd. | 03/23/2022SE |
| K213894 | DWFritz ASM2000FXX · Traditional | Dwfritz Automation, Inc. | 03/14/2022SE |
| K212330 | Yadu Medical Face Mask (Level 1)FXX · Traditional | Henan Yadu Industrial Co., Ltd. | 03/14/2022SE |
| K213806 | Disposable Medical Face MaskFXX · Traditional | Xiantao Zhibo Nonwoven Products Co., Ltd. | 03/12/2022SE |
| K214087 | Medical Face MaskFXX · Traditional | Hubei Medlink Healthcare Co., Ltd. | 03/08/2022SE |
| K213358 | Surgical MaskFXX · Traditional | Shenzhen Safesecure Medical Infection Control… | 03/04/2022SE |
| K203376 | ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400GFXX · Traditional | Medtecs (Taiwan) Corp. | 03/02/2022SE |
| K214094 | ROKI Surgical MaskFXX · Traditional | Roki Co., Ltd. | 02/24/2022SE |
| K213724 | Medical Surgical MaskFXX · Traditional | Hunan Zhenheyikang Medical Instrument Co., Ltd. | 02/20/2022SE |
| K212863 | Surgical Face MaskFXX · Traditional | Taiwan Comfort Champ Manufacturing Co., Ltd. | 02/19/2022SE |
| K212366 | Heartland Health Surgical MaskFXX · Abbreviated | Heartland Health Products | 02/19/2022SE |
| K213617 | Surgical Face MaskFXX · Traditional | Megasoft (China) Co., Ltd. | 02/11/2022SE |
| K212120 | Surgical MasksFXX · Traditional | Hubei Xinxin Non-Woven Co., Ltd. | 01/28/2022SE |
| K212610 | Surgical Face MaskFXX · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 01/26/2022SE |
| K210101 | American-Made Surgical MaskFXX · Abbreviated | Armbrust, Inc. | 01/26/2022SE |
| K213347 | ADI Medical Surgical Face MaskFXX · Traditional | Asia Dynamics Inc., D/B/A Adi Medical | 01/25/2022SE |
| K213970 | D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 PlyFXX · Traditional | Danameco Medical Joint Stock Corporation | 01/23/2022SE |
| K212111 | Myflon Surgical Mask Level 3FXX · Traditional | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri… | 01/23/2022SE |
| K203161 | Surgical Face MaskFXX · Traditional | Wuhan Raytex Protection Co., Ltd. | 01/20/2022SE |
| K212826 | Disposable Medical MaskFXX · Traditional | Jiangsu Nanfang Medical Co., Ltd. | 01/19/2022SE |
| K210679 | Medical Face MaskFXX · Traditional | Wuxi Yushou Medical Appliances Co., Ltd. | 01/18/2022SE |
| K212994 | Medical Face MaskFXX · Traditional | Guangzhou Quantum Laser Intelligent Equipment… | 01/17/2022SE |
| K213920 | Kangbeier Surgical Mask (Model: KBR-1001)FXX · Traditional | Xinxiang Kangbeier Medical Technology Co., Ltd. | 01/16/2022SE |
| K211833 | Disposable Medical Face MaskFXX · Traditional | Zhejiang the Purples Protective Products Co.,Ltd | 01/16/2022SE |
| K212997 | Surgical MaskFXX · Traditional | Guangdong Zhizhen Biological Medical Co., Ltd. | 01/14/2022SE |
| K212913 | Surgical Face MaskFXX · Traditional | Jiangxi Ganlong Pharmaceutical Co., Ltd. | 01/14/2022SE |
| K211260 | Sheng Jing Tang Surgical MaskFXX · Traditional | Liaoning Shengjingtang Biotechnology Co., Ltd. | 01/10/2022SE |
| K212375 | Disposable Medical Surgical MaskFXX · Traditional | Jiangxi Bestgrand Health Technology Co., Ltd. | 01/04/2022SE |
| K212299 | Medical Surgical MaskFXX · Traditional | Wepon Medical Technology Co., Ltd. | 01/04/2022SE |
| K213136 | CPL Surgical Face MaskFXX · Traditional | Control Print Limited | 12/24/2021SE |
| K202255 | Skypro, SP02 Mask (3)FXX · Traditional | Skypro Medical Supplies Company | 12/24/2021SE |
| K210147 | Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face…FXX · Traditional | Unicoglobal, Inc. | 12/22/2021SE |
| K211750 | Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)FXX · Traditional | National Bridge Industrial (S.Z.) Co., Ltd. | 12/20/2021SE |
| K212059 | Surgical Face MaskFXX · Traditional | Zhongshan Saifute Labor Protective Articles Co.… | 12/17/2021SE |
| K210102 | Topwide Surgical Face MaskFXX · Traditional | Topwide (Hubei) Medical Products Manufacturer | 12/17/2021SE |
| K211378 | LM Surgical Mask Level 3, LM Surgical Mask Level 2,FXX · Traditional | Liberty Mask, LLC | 12/16/2021SE |
| K212944 | Disposable Surgical MaskFXX · Traditional | Heilongjiang Yinjia Medical Equipment Co., Ltd. | 12/15/2021SE |
| K212398 | Surgical Face Mask (Non-sterile)FXX · Traditional | Hubei Kimsoul Industrial Co., Ltd. | 12/15/2021SE |
| K212574 | Surgical Face MaskFXX · Traditional | Xiantao Deming Healthcare Products Co., Ltd. | 12/14/2021SE |
| K210744 | Surgical MaskFXX · Traditional | Chongqing PA Xijia Biotechnology Co., Ltd. | 12/14/2021SE |
| K202794 | Surgical face mask: F-Y1-AFXX · Traditional | Jiande Chaomei Daily Chemicals Co., Ltd. | 12/13/2021SE |
| K212867 | Medical Surgical MaskFXX · Traditional | Nanchang Kanghua Health Materials Co., Ltd. | 12/11/2021SE |
| K211487 | MAF GuardFXX · Abbreviated | Maf Clothing Pvt Ltd Unit-3 | 12/08/2021SE |
| K212302 | BAYLAB 3-Ply Surgical Mask (BEACON I)FXX · Traditional | Baylab USA, LLC | 12/07/2021SE |
| K212235 | Surgical Face MaskFXX · Traditional | Shanghai Yunqing Industrial Co., Ltd. | 12/06/2021SE |
| K211772 | PMW01 Procedure Mask Level 1FXX · Abbreviated | Defender Safety, Inc. | 12/06/2021SE |
| K212807 | Surgical MasksFXX · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 12/03/2021SE |
| K212740 | Puravita Medical Fold Flat Surgical MaskFXX · Traditional | Puravita M, LLC | 12/02/2021SE |
| K211773 | Single-use Surgical MaskFXX · Traditional | Taiwan Seafood and Fish Corporation | 12/02/2021SE |
| K211696 | Disposable Surgical Face MaskFXX · Traditional | Anhui Cleanpro Pharmpack Co., Ltd. | 11/30/2021SE |
| K202842 | Medical surgical maskFXX · Traditional | Henan Huibo Medical Co., Ltd. | 11/26/2021SE |
| K211295 | Surgical Mask (sterile)FXX · Traditional | Nanjing 3h Medical Products Co., Ltd. | 11/24/2021SE |
| K211956 | 039 Surgical Face MaskFXX · Traditional | Aok Tooling Limited | 11/23/2021SE |
| K213406 | Savvy Mask - Level 3 Surgical Face MaskFXX · Traditional | Texas Medplast, LLC | 11/18/2021SE |
| K212046 | Impertech Surgical Face MaskFXX · Traditional | Impertech Industries , Ltd. | 11/18/2021SE |
| K210042 | Disposable Surgical MaskFXX · Traditional | Suzhou Letian Protective Products Co., Ltd. | 11/17/2021SE |
| K212344 | Surgical MaskFXX · Traditional | Xiantao Dingcheng Non-Woven Product Co., Ltd. | 11/16/2021SE |
| K212575 | Surgical Face MaskFXX · Traditional | Hubei Huanfu Plastic Products Co., Ltd. | 11/14/2021SE |
| K212109 | Spin Care Disposable Protective Mask Level 3FXX · Traditional | Spintech, LLC | 11/14/2021SE |
| K212264 | Surgical Face maskFXX · Traditional | Nantong Taiweishi Medical Technology Co., Ltd. | 11/13/2021SE |
| K212526 | Surgical Face MaskFXX · Traditional | Suzhou Janee Medical Technology Co., Ltd. | 11/09/2021SE |
| K211165 | Medical Face Masks, Model Name:MY020003FXX · Traditional | Huizhou Jie Bai Purification Co., Ltd. | 11/09/2021SE |
| K212460 | Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))FXX · Traditional | Guangzhou Zhengkang Medical Equipment Co.,Ltd | 11/05/2021SE |
| K202676 | Disposable Medical Face MaskFXX · Traditional | Zhejiang Senhong Medical&Instrument Co., Ltd. | 11/05/2021SE |
| K212471 | Medical Face MaskFXX · Traditional | Haian Medigauze Co., Ltd. | 11/04/2021SE |
| K210222 | Disposable Medical MaskFXX · Traditional | Guangdong Lide Medical Technology Co., Ltd. | 11/02/2021SE |
| K212293 | Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)FXX · Traditional | Jiangmen Ningrui Medical Supplies Co., Ltd. | 10/25/2021SE |
| K212368 | Surgical Face MaskFXX · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 10/24/2021SE |
| K210348 | Disposable Medical Surgical MaskFXX · Traditional | Weihai Dishang Medical Technology Co., Ltd. | 10/24/2021SE |
| K203565 | Surgical 3D MaskFXX · Traditional | Inno Lifecare | 10/19/2021SE |
| K212205 | Medical Protective MasksFXX · Traditional | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 10/14/2021SE |
| K210845 | Disposable Surgical Mask (Model: YYKZ-01)FXX · Traditional | Jiaxing Amazing Travel-Ware Co., Ltd. | 10/12/2021SE |
| K210813 | Medical Surgical MaskFXX · Traditional | Sichuan Pharmaceutical., Inc. | 10/08/2021SE |
| K210622 | Single-Use Medical Face MaskFXX · Traditional | Jiangxi Hongda Medical Equipment Group Co., Ltd. | 10/08/2021SE |
| K211899 | Surgical Face MaskFXX · Traditional | Hubei Yi-Ya Protective Products Co., Ltd. | 10/04/2021SE |
| K211425 | Private Stock Labs Surgical Face MaskFXX · Traditional | J.K. Private Stock, Inc. | 10/04/2021SE |
| K210513 | UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2FXX · Traditional | Universal Incorporation | 09/29/2021SE |
| K211794 | Disposable surgical maskFXX · Traditional | Shanghai No.9 Knitting Mill Co., Ltd. | 09/28/2021SE |
| K210878 | Surgical Face Mask (Model: CM2006, CM2008, A88)FXX · Traditional | Shenzhen Realtone Medical Appliance Co., Ltd. | 09/28/2021SE |
| K210908 | Surgical MaskFXX · Traditional | Sichuan Prius Biotechnology Co., Ltd. | 09/26/2021SE |
| K211827 | Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)FXX · Traditional | Zhejiang Lanhine Medical Products, Ltd. | 09/23/2021SE |
| K211097 | Banyan USA Surgical Mask Level 3FXX · Traditional | Banyan USA, LLC | 09/22/2021SE |
| K210772 | 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)FXX · Traditional | Vr Vertical, LLC Dba Xrgo | 09/22/2021SE |
| K211751 | WELLTRUST WT-III Mask with Flat EarloopFXX · Traditional | Lonestar Meadows, LLC | 09/17/2021SE |
| K203418 | Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))FXX · Traditional | Ningbo Ouhan Medical Device Co., Ltd. | 09/17/2021SE |
| K203112 | Disposable Medical MaskFXX · Traditional | Yangzhou Runyi Arts & Crafts Co., Ltd. | 09/16/2021SE |
| K210184 | Wilson Tech Disposable Medical Face MaskFXX · Traditional | Wilson Tech (International) Limited | 09/14/2021SE |
| K203455 | Disposable Medical MaskFXX · Traditional | Fujian Kang Chen Daily Necessities Co., Ltd. | 09/13/2021SE |
| K211296 | Surgical face maskFXX · Traditional | Sunsmed Protective Products , Ltd. | 09/11/2021SE |
| K212451 | Surgical MaskFXX · Traditional | Remade USA, LLC | 09/10/2021SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0729-2025 Class II | O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks… | O&M Halyard, Inc. | 11/08/2024Open, Classified |
| Z-0728-2025 Class II | O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask…Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks… | O&M Halyard, Inc. | 11/08/2024Open, Classified |
| Z-1148-2024 Class II | PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)Level 3 masks were produced on alternate non-validated production equipment that were not included as part… | AMD Medicom Inc. | 12/21/2023Open, Classified |
| Z-1147-2024 Class II | HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)Level 3 masks were produced on alternate non-validated production equipment that were not included as part… | AMD Medicom Inc. | 12/21/2023Open, Classified |
| Z-1146-2024 Class II | HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)Level 3 masks were produced on alternate non-validated production equipment that were not included as part… | AMD Medicom Inc. | 12/21/2023Open, Classified |
| Z-1059-2023 Class III | FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange…Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the… | Owens & Minor Distribution, Inc. | 01/03/2023Open, Classified |
| Z-0495-2020 Class II | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes.… | AMD Medicom Inc. | 10/11/2019Terminated |
| Z-0494-2020 Class II | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes.… | AMD Medicom Inc. | 10/11/2019Terminated |
| Z-1451-2013 Class II | Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, #…Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of… | Maytex Corp | 05/15/2013Terminated |