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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 K112924
Device Name RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME
Applicant
Riverstone Resources Sdn Bhd
Lot 56, # 15, Jalan Jasmin 2
Bukit Beruntung, Selangor,  MY 48300
Applicant Contact CHONG CHU MEE
Correspondent
Riverstone Resources Sdn Bhd
Lot 56, # 15, Jalan Jasmin 2
Bukit Beruntung, Selangor,  MY 48300
Correspondent Contact CHONG CHU MEE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/03/2011
Decision Date 05/02/2012
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
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