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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 K253003
Device Name Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
Applicant
Hubei Xinxin Non-Woven Co., Ltd.
Taizihu Industrial Park, Pengchang Town
Xiantao,  CN 433018
Applicant Contact Nicole Jin
Correspondent
Hubei Xinxin Non-Woven Co., Ltd.
Taizihu Industrial Park, Pengchang Town
Xiantao,  CN 433018
Correspondent Contact Nicole Jin
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/19/2025
Decision Date 04/20/2026
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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