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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 K223444
Device Name Powder Free Blue Nitrile Examination Glove
Applicant
S&S Glove Corporation
Lot 4, D6 St., Dat Do I Industrial Park
Phuoc Long Tho Commune
Ba Ria-Vung Tau,  VN VN790000
Applicant Contact Poppy Farrah Rossa
Correspondent
Registrar Corp.
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact David Lennarz
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/14/2022
Decision Date 02/06/2023
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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