Henan Yadu Level 4 Surgical Gowns (Reinforced)— 510(k) K252301

Name: FDA 510(k) clearance K252301
Creator: U.S. Food and Drug Administration
Published: 2026-02-04

Substantially Equivalent

Yadu Medical (Henan) Co., Ltd.

FDA 510(k) clearance K252301 for Henan Yadu Level 4 Surgical Gowns (Reinforced), Substantially Equivalent on 2026-02-04. Applicant: Yadu Medical (Henan) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yadu Medical (Henan) Co., Ltd.
Product code: Code FYA
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2025-07-24
Decision date: 2026-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: He Nan, CN

Download summary PDF View on FDA.gov ↗

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