Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)— 510(k) K261028
Substantially EquivalentYadu Medical (Henan) Co., Ltd.
FDA 510(k) clearance K261028 for Surgical Gown Level2 (S, M, L, XL, XXL, XXXL), Substantially Equivalent on 2026-08-07. Applicant: Yadu Medical (Henan) Co., Ltd.. Device class: 2.
Summary
Yadu Medical (Henan) filed a Surgical Gown Level2 in sizes S through XXXL under product code FYA, surgical gowns.
Class II, 21 CFR 878.4040. The General Hospital review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Yadu filed from He Nan, China. The substantially equivalent decision came 130 calendar days after receipt (March 30 to August 7, 2026).
Clearance details
- Applicant
- Yadu Medical (Henan) Co., Ltd.
- Product code
- Product code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- He Nan, CN
Recent devices under product code FYA
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- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
- K253243 — Cardinal Health Poly Reinforced Surgical Gown
More clearances from Yadu Medical (Henan) Co., Ltd.
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