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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 K253243
Device Name Cardinal Health™ Poly Reinforced Surgical Gown
Applicant
Cardinal Health 200, LLC
3651 Birchwood Dr.
Waukegan,  IL  60085
Applicant Contact Astha Jaiswal
Correspondent
Cardinal Health 200, LLC
3651 Birchwood Dr.
Waukegan,  IL  60085
Correspondent Contact Yuan Zhou
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/29/2025
Decision Date 04/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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