Cleared Traditional

Copioumed AAMI 3 Surgical Gown

K251860 · Copioumed International, Inc. · General Hospital

Feb 2026

Decision

254d

Days

Class 2

Risk

About This 510(k) Submission

K251860 is an FDA 510(k) clearance for the Copioumed AAMI 3 Surgical Gown, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Copioumed International, Inc. (Taipei City, TW). The FDA issued a Cleared decision on February 26, 2026, 254 days after receiving the submission on June 17, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K251860 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2025
Decision Date	February 26, 2026
Days to Decision	254 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF