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