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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K251860
Device Name Copioumed AAMI 3 Surgical Gown
Applicant
Copioumed International, Inc.
16f-4, #1, Fuxing N. Rd., Songshan Dist.
Taipei City,  TW 105
Applicant Contact James Liu
Correspondent
Ruscert Technology Co., Ltd.
8f., # 187, Lequn 2nd Rd., Zhongshan Dist.
Taipei City,  TW 10462
Correspondent Contact Ming-Yie Jan
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/17/2025
Decision Date 02/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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