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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K253508
Device Name Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile
Applicant
Vietglove Corporation
Land Lot # 3, Map No 37, Cau Sat Hamlet, Ben Cat Ward
Ho Chi Minh,  VN 75950
Applicant Contact Harry Vuong
Correspondent
Vietglove Corporation
Land Lot # 3, Map No 37, Cau Sat Hamlet, Ben Cat Ward
Ho Chi Minh,  VN 75950
Correspondent Contact Harry Vuong
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/03/2025
Decision Date 10/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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