Cleared Traditional

Henan Yadu Level 4 Surgical Gowns (Reinforced)

K252301 · Yadu Medical (Henan) Co., Ltd. · General Hospital

Feb 2026

Decision

195d

Days

Class 2

Risk

About This 510(k) Submission

K252301 is an FDA 510(k) clearance for the Henan Yadu Level 4 Surgical Gowns (Reinforced), 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 February 4, 2026, 195 days after receiving the submission on July 24, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K252301 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2025
Decision Date	February 04, 2026
Days to Decision	195 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF