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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K252467
Device Name Disposable Vinyl Examination Gloves
Applicant
Viet Phu Trade and Import Export Co., Ltd.
No 58, Km 433
Kim Son
Dong Trieu,  VN 526300
Applicant Contact Kim Ngan Pham Thi
Correspondent
Viet Phu Trade and Import Export Co., Ltd.
No 58, Km 433
Kim Son
Dong Trieu,  VN 526300
Correspondent Contact Kim Ngan Pham Thi
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/06/2025
Decision Date 10/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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