Cleared Traditional

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

K250564 · Yadu Medical (Henan) Co., Ltd. · General Hospital

Dec 2025

Decision

280d

Days

Class 2

Risk

About This 510(k) Submission

K250564 is an FDA 510(k) clearance for the Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL), a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Yadu Medical (Henan) Co., Ltd. (He Nan, CN). The FDA issued a Cleared decision on December 3, 2025, 280 days after receiving the submission on February 26, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K250564 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2025
Decision Date	December 03, 2025
Days to Decision	280 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF