| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026-05-12 |
| K253243 | Cardinal Health Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | 2026-04-28 |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | Hubei Xinxin Non-Woven Co., Ltd. | 2026-04-20 |
| K251860 | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | 2026-02-26 |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. | 2026-02-04 |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2025-12-03 |
| K243522 | ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH | 2025-05-30 |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) | 2025-05-05 |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP | 2025-02-26 |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Stryker Instruments | 2024-10-16 |
| K241214 | ProPel SG3 Surgical Gown | Standard Textile Co., Inc. | 2024-09-10 |
| K233571 | GCI Surgical Gown | George Courey, Inc. | 2024-08-02 |
| K233068 | Disposable Surgical Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2024-03-29 |
| K233183 | Surgical Gown (40083) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2024-02-01 |
| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | 2023-10-12 |
| K230610 | Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) | Dongguan Shin YI Healthcare Products Factory | 2023-08-23 |
| K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2023-08-22 |
| K230577 | Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi | 2023-08-16 |
| K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets | Cardinal Health200, LLC | 2023-07-27 |
| K222999 | Surgical Gown | Hubei Woozon Healthcare Co., Ltd. | 2023-06-16 |
| K222456 | High Protection Surgical Gown | 3A Medical Products Co., Ltd. | 2023-03-12 |
| K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023-03-07 |
| K221559 | Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 | Stringking | 2023-02-23 |
| K213844 | Surgical Gown | Bayteks Teknik Tekstil San. VE Tic. A.S. | 2023-02-16 |
| K220435 | SEJONG Surgical Gown Soft | Sejong Healthcare Co., Ltd. | 2023-02-10 |
| K222403 | Surgical Gown | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 2023-01-26 |
| K213893 | Comfort Gown, Safewear Gown | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2022-12-21 |
| K212812 | Surgical Gown | Xianning Marveldas Protective Articles Co., Ltd. | 2022-11-16 |
| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) | Foshan Nanhai Plus Medical Co, Ltd. | 2022-11-14 |
| K221139 | Bodygard SFS Surgical Gown Level 4 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri | 2022-11-10 |