FYA
- 产品代码
- FYA
- 器械名称
- Gown, Surgical
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.4040
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 19 件
- 其中 Summary 已存档
- 14 份，可直接下载
- FDA 历史累计 510(k)
- 298 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（19 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| 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 |
FDA 官方分类页： FYA
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。