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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 K100603
Device Name RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
Applicant
RIVERSTONE RESOURCES SDN. BHD.
JALAN JASMIN 2
48300 BUKIT BERUNTUNG
SELANGOR,  MY 48300
Applicant Contact CHONG CHU MEE
Correspondent
RIVERSTONE RESOURCES SDN. BHD.
JALAN JASMIN 2
48300 BUKIT BERUNTUNG
SELANGOR,  MY 48300
Correspondent Contact CHONG CHU MEE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/03/2010
Decision Date 07/16/2010
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
Recalls CDRH Recalls
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