FYA
- Product code
- FYA
- Device name
- Gown, Surgical
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 298
510(k) clearances, last 3 years (19)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260407 | 2026-08-26 | Principle & Will Co., Ltd. | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-steril | — |
| K261028 | 2026-08-07 | Yadu Medical (Henan) Co., Ltd. | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | |
| K261949 | 2026-07-10 | New York Embroidery Studio | NYES Tuff Cuff L3 Disposable Gowns | — |
| K252575 | 2026-06-04 | New York Embroidery Studio (NYES) | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile | — |
| K260725 | 2026-05-12 | Hindernis DE Mexico, S.A.P.I. DE C.V. | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | |
| K253243 | 2026-04-28 | Cardinal Health 200, LLC | Cardinal Health Poly Reinforced Surgical Gown | — |
| K253003 | 2026-04-20 | Hubei Xinxin Non-Woven Co., Ltd. | Non-sterile Level 3 Surgical Gown (4025); Sterile Le | |
| K251860 | 2026-02-26 | Copioumed International, Inc. | Copioumed AAMI 3 Surgical Gown | |
| K252301 | 2026-02-04 | Yadu Medical (Henan) Co., Ltd. | Henan Yadu Level 4 Surgical Gowns (Reinforced) | |
| K250564 | 2025-12-03 | Yadu Medical (Henan) Co., Ltd. | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | |
| K243522 | 2025-05-30 | Thi Total Healthcare Innovation GmbH | ViVi® Toga Premium | |
| K242937 | 2025-05-05 | Dae Myung Chemical Co., Ltd. (Vietnam) | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | |
| K242844 | 2025-02-26 | Medline Industries, LP | Medline Level 4 Surgical Gown with Breathable Sleeve | |
| K241272 | 2024-10-16 | Stryker Instruments | Stryker Steri-Shield 8 Surgical Hoods and Togas | |
| K241214 | 2024-09-10 | Standard Textile Co., Inc. | ProPel SG3 Surgical Gown | |
| K233571 | 2024-08-02 | George Courey, Inc. | GCI Surgical Gown | |
| K233068 | 2024-03-29 | Nanning Tecbod Biological Technology C | Disposable Surgical Gown | — |
| K233183 | 2024-02-01 | Ammex-Weida (Hubei) Health and Safety | Surgical Gown (40083) | |
| K230707 | 2023-10-12 | Skypro Medical Supplies Company | Skypro, Surgical Gown 6021 |
Official FDA classification page: FYA
Classification and pathway per current FDA publications. Data from openFDA (CC0).