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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 K231439
Device Name Powder Free White, Black, and Purple Nitrile Examination Glove
Applicant
S&S Glove Corporation
Lot 4, D6 Rd., Dat Do I Industrial Park
Phuoc Long Tho Commune
Ba Ria-Vung Tau,  VN VN790000
Applicant Contact Poppy Farrah Rossa
Correspondent
S&S Glove Corporation
Lot 4, D6 Rd., Dat Do I Industrial Park
Phuoc Long Tho Commune
Ba Ria-Vung Tau,  VN VN790000
Correspondent Contact Poppy Farrah Rossa
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/17/2023
Decision Date 08/11/2023
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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