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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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