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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K902956
Device Name LATEX EXAMINATION GLOVES
Applicant
Pacificlink Export Industries Private , Ltd.
C/O Poseidon Marine Consultant
P.O. Box 13545, Station A
St John'S Nfld Canada,  CA
Applicant Contact A PAGARKAR
Correspondent
Pacificlink Export Industries Private , Ltd.
C/O Poseidon Marine Consultant
P.O. Box 13545, Station A
St John'S Nfld Canada,  CA
Correspondent Contact A PAGARKAR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/05/1990
Decision Date 11/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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