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 1 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | O&M Halyard, Inc. | 2026-03-18 | Traditional | PDF ↗ |
| K252534 | Surgical Face Mask (Ear mount) | Zhejiang Hangkang Medical Equipment Co., Ltd. | 2026-03-03 | Traditional | PDF ↗ |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | Efofex, Inc. | 2026-02-19 | Special | PDF ↗ |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900) | Beatles Medical Supplies (Xiantao) Co., Ltd. | 2026-01-12 | Traditional | PDF ↗ |
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | 2026-01-05 | Traditional | PDF ↗ |
| K243342 | KP Protective Face Mask | Kp Trading Co., Ltd. | 2025-12-22 | Traditional | PDF ↗ |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. | 2025-12-11 | Traditional | PDF ↗ |
| K252964 | PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. | 2025-11-04 | Traditional | PDF ↗ |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) | Vitacore Industries, Inc. | 2025-09-17 | Traditional | PDF ↗ |
| K250082 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2025-06-18 | Traditional | PDF ↗ |
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce | Owens & Minor (O&M) Halyard, Inc. | 2025-05-30 | Abbreviated | PDF ↗ |
| K242502 | Aurelia Surgical Mask ASTM Level-3 (2130) | Supermax Healthcare Canada Supermax Medical | 2024-11-12 | Traditional | PDF ↗ |
| K240916 | Surgical Face Mask (Tie on/ Ear loops) | Xiantao Daoqi Plastic Co., Ltd. | 2024-10-18 | Traditional | PDF ↗ |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | Primed Medical Products, Inc. | 2024-08-26 | Traditional | PDF ↗ |
| K233723 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2024-07-29 | Traditional | PDF ↗ |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) | Owens & Minor (O&M) Halyard, Inc. | 2024-07-02 | Traditional | PDF ↗ |
| K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) | Owens & Minor (O&M) Halyard, Inc. | 2024-07-01 | Traditional | PDF ↗ |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-21 | Traditional | PDF ↗ |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-14 | Traditional | PDF ↗ |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-07 | Traditional | PDF ↗ |
| K232968 | Grande Medical Masks, Model SF-600 | Golden Grande Corp. | 2024-06-06 | Traditional | PDF ↗ |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-04 | Traditional | PDF ↗ |
| K240258 | Disposable Medical Face Mask (M643BE) | Makrite Industries, Inc. | 2024-04-18 | Traditional | PDF ↗ |
| K232112 | R&G Surgical Mask | R&G Seguridad E Higiene Industrial S.A.C. | 2024-04-02 | Traditional | PDF ↗ |
| K231719 | Medical Surgical Mask | Azur Medical Company, Inc. | 2024-03-19 | Traditional | PDF ↗ |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) | Owens & Minor (O&M) Halyard, Inc. | 2024-01-08 | Traditional | PDF ↗ |
| K232797 | Hygenix | Shenzhen Hygenix Industrial Co., Ltd. | 2023-12-11 | Traditional | PDF ↗ |
| K231005 | Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 | Supermax Healthcare Canada-Supermax Medical | 2023-12-05 | Traditional | PDF ↗ |
| K231155 | Biodegradable Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-11-07 | Traditional | PDF ↗ |
| K232359 | Surgical face mask | Kingstar Medical (Xianning) Co., Ltd. | 2023-10-02 | Traditional | PDF ↗ |
| K230380 | Surgical Face Masks, Model: EFMDS-L50Pn BLU | Iris USA | 2023-08-03 | Traditional | PDF ↗ |
| K231618 | 3 Layer Surgical Mask (134252531) | Original Mattress Factory, Inc. | 2023-07-28 | Traditional | PDF ↗ |
| K230395 | Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) | Durio Ppe Sdn Bhd | 2023-07-17 | Traditional | PDF ↗ |
| K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) | Cardinalhealth | 2023-07-03 | Abbreviated | PDF ↗ |
| K230617 | Surgical Face Mask (L 175*95mm) | Henan Chaoya Medical Equipment Co., Ltd. | 2023-06-01 | Traditional | PDF ↗ |
| K222545 | Disposable Medical Mask | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 2023-05-19 | Traditional | PDF ↗ |
| K223823 | Disposable Surgical Face Mask | Efofex, Inc. | 2023-03-27 | Traditional | PDF ↗ |
| K223236 | Medline Surgical Face Mask and Medline Procedural Face Mask | Medline Industries, LP | 2023-03-24 | Traditional | PDF ↗ |
| K221352 | Surgical Face Mask | Wuhan Huashida Protective Products Co., Ltd. | 2023-03-13 | Traditional | PDF ↗ |
| K221209 | PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops | Padm Medical, Inc. | 2023-03-08 | Traditional | PDF ↗ |
| K230383 | Savvy Surgical Mask - Level 3 | Alg Health, LLC | 2023-03-06 | Traditional | PDF ↗ |
| K223232 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2023-03-06 | Traditional | PDF ↗ |
| K230093 | Disposable 4 Layers Surgical Face Mask | Social Medical Supply, LLC | 2023-03-02 | Traditional | PDF ↗ |
| K223686 | Medical Protective Masks | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 2023-02-07 | Traditional | PDF ↗ |
| K221682 | Ideal Med Pro 3-Ply Disposable Face Mask | Jsn Holdings, LLC | 2023-01-13 | Traditional | PDF ↗ |
| K203380 | Disposable Surgical Face Mask | Shandong Pop Jeans Intelligent Manufacturing Co., Ltd. | 2023-01-06 | Traditional | PDF ↗ |
| K222483 | Surgical Face Mask | Hubei Woozon Healthcare Co., Ltd. | 2023-01-04 | Traditional | PDF ↗ |
| K222809 | Medical Disposable Face Masks | Anqing Mayfield Medical Limited | 2023-01-03 | Traditional | PDF ↗ |
| K213601 | Surgical Mask | Wuhan Zonsen Medical Products Co., Ltd. | 2022-12-16 | Traditional | PDF ↗ |
| K220520 | PM Excellence SEQUR 100 Surgical Face Mask | Pm Excellence, LLC | 2022-12-15 | Traditional | PDF ↗ |
| K222651 | Surgical Face Mask | Xiantao Sanda Industrial Co., Ltd. | 2022-12-13 | Traditional | PDF ↗ |
| K223045 | 3-Ply Disposable Medical Mask | Wealth Lead Industrial Limited | 2022-12-07 | Traditional | PDF ↗ |
| K223055 | Disposable Medical Face Mask | Xiantao Zhuobo Industrial Co., Ltd. | 2022-12-05 | Traditional | PDF ↗ |
| K223068 | Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) | Guangdong Golden Leaves Technology Development Co., Ltd. | 2022-11-23 | Traditional | PDF ↗ |
| K223003 | Banded Face Mask | Hubei Medlink Healthcare Co., Ltd. | 2022-11-18 | Special | PDF ↗ |
| K220302 | Disposable surgical face mask | Shandong Aida Medical Products Co., Ltd. | 2022-11-16 | Abbreviated | PDF ↗ |
| K203528 | KNH Surgical Face Mask | Knh Surgical Face Mask | 2022-11-16 | Traditional | PDF ↗ |
| K222529 | Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | 2022-11-14 | Traditional | PDF ↗ |
| K222749 | High Fluid-Resistant Surgical and Procedure Mask | AmericaS Supply Chains | 2022-11-14 | Traditional | PDF ↗ |
| K222551 | Humask Pro Vision, Humask Pro Vision 3000 | Entreprise Premont, Inc. | 2022-11-10 | Abbreviated | PDF ↗ |
| K222697 | Disposable Medical Face Mask (DF3-001) | Wellmed Dental Medical Supply Co., Ltd. | 2022-11-04 | Traditional | PDF ↗ |
| K223270 | POSE Health Care Surgical Mask | America'S Supply Chains | 2022-11-01 | Traditional | PDF ↗ |
| K212649 | Disposable Surgical Face Mask | Lyncmed Medical Technology (Beijing) Co., Ltd. | 2022-10-25 | Traditional | PDF ↗ |
| K222335 | Surgical Mask | Luoyang Sunmed Devices Co., Ltd. | 2022-10-11 | Traditional | PDF ↗ |
| K222266 | Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | 2022-09-26 | Traditional | PDF ↗ |
| K222204 | Medical Surgical Mask | Guangzhou Zhengkang Medical Equipment Co.,Ltd | 2022-09-23 | Traditional | PDF ↗ |
| K221976 | Surgical Face Mask (Non-sterile) | Xiantao Junhui Plastic Products Co., Ltd. | 2022-09-20 | Traditional | PDF ↗ |
| K212926 | AllureTM Surgical Mask | Allure Gift Wraps Private Limited | 2022-09-16 | Traditional | PDF ↗ |
| K221534 | Surgical Face Masks (Ear Loops And Tie-On) | San-M Package Co., Ltd. | 2022-09-16 | Traditional | PDF ↗ |
| K214035 | LAITEST Medical Face Mask | R&R Medical Corporation, Ltd. | 2022-09-13 | Traditional | PDF ↗ |
| K220944 | PointCore Surgical Mask | Pointcore, Inc. | 2022-09-09 | Traditional | PDF ↗ |
| K222426 | Perfetta Moderate Medical Face Mask | Phu Bao Group Company Limited | 2022-09-02 | Traditional | PDF ↗ |
| K221957 | Savewo ClassicMASK | Savewo Limited | 2022-09-02 | Traditional | PDF ↗ |
| K221038 | Disposable Medical Masks | Hantech Medical Device Co., Ltd. | 2022-09-01 | Traditional | PDF ↗ |
| K220067 | Medical Surgery Mask, Model:2626-7 | Dongguan Missadola Technology Co., Ltd. | 2022-08-30 | Traditional | PDF ↗ |
| K211771 | The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask | The Good Corporation | 2022-08-24 | Traditional | PDF ↗ |
| K203078 | CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW | Huizhou Tianchang Industrial Co., Ltd. | 2022-08-19 | Abbreviated | PDF ↗ |
| K212273 | Cross Protection ResQ300 Plus Surgical Face Mask | Cross Protection (M) Sdn Bhd | 2022-08-17 | Traditional | PDF ↗ |
| K221838 | Surgical Face Mask (HNFM0103) | Shanghai Hua EN Industrial Co, Ltd. | 2022-08-17 | Traditional | PDF ↗ |
| K220876 | AOK 95A Medical Mask (20200049) | Aok Tooling Limited | 2022-07-27 | Traditional | PDF ↗ |
| K221409 | Paneffort 3-ply Surgical and Procedural Masks | Paneffort, LLC | 2022-07-25 | Traditional | PDF ↗ |
| K221196 | Disposable Medical Face Mask (ear loop) | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | 2022-07-22 | Traditional | PDF ↗ |
| K220777 | Surgical face mask | Hubei Qianjiang Kingphar Medical Material Co., Ltd. | 2022-07-19 | Traditional | PDF ↗ |
| K221173 | Surgical Mask (Model: 0868F, 0866F) | Jiangxi Sanhao Medical Instruments Co.,Ltd | 2022-07-06 | Traditional | PDF ↗ |
| K220378 | Sparta 3-Ply Surgical Disposable Face Mask | Sparta East, LLC | 2022-06-30 | Traditional | PDF ↗ |
| K221273 | Medical Face Mask (M001) | Xingyu Medical Tech Co., Ltd. | 2022-06-28 | Traditional | PDF ↗ |
| K220670 | Magnum | Magnum Health and Safety Pvt, Ltd. | 2022-06-28 | Traditional | PDF ↗ |
| K221272 | Medical Face Mask | Shandong Xingyu Gloves Co., Ltd. | 2022-06-28 | Traditional | PDF ↗ |
| K220377 | Procedure Mask | Little Rapids Corporation | 2022-06-24 | Traditional | PDF ↗ |
| K220550 | Disposable Surgical Face Mask (M663BE, M663BT) | Makrite Industries, Inc. | 2022-06-14 | Traditional | PDF ↗ |
| K221222 | Surgical Face Mask (HNFM0304) | Shanghai Hua EN Industrial Co, Ltd. | 2022-06-06 | Traditional | PDF ↗ |
| K220597 | Disposable Surgical Face Mask (FM-34EE,FM-44EE) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2022-05-26 | Traditional | PDF ↗ |
| K220191 | Disposable Face Mask | Jiujiang Taixin Technology Co., Ltd. | 2022-05-24 | Traditional | PDF ↗ |
| K220532 | Disposable surgical mask | Xiamen Blue Star Enterprise Co., Ltd. | 2022-05-23 | Traditional | PDF ↗ |
| K221134 | Procedure Mask with Ear Loops and Surgical Mask with Ties | Safesource Direct, LLC | 2022-05-19 | Traditional | PDF ↗ |
| K220824 | Medical Surgical Mask (Planar type) | Hunan Chopard Medical Devices Co., Ltd. | 2022-05-19 | Traditional | PDF ↗ |
| K220194 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2022-05-17 | Traditional | PDF ↗ |
| K220749 | Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP | Unimax Medical Products Co., Ltd. | 2022-05-13 | Traditional | PDF ↗ |
| K213001 | Procedure Mask, Surgical Mask | A Plus International, Inc. | 2022-05-11 | Traditional | PDF ↗ |
| K220487 | Disposable Medical Face Mask | Hubei Mediunion Medical Products Co., Ltd. | 2022-04-26 | Traditional | PDF ↗ |
Product code FXX · Class II · General, Plastic Surgery. Data: openFDA.