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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 K100611
Device Name RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)
Applicant
Riverstone Resources Sdn Bhd
Kawasan Perindustrian Bukit
48300 Bukit Beruntung
Selangor,  MY
Applicant Contact CHONG CHU MEE
Correspondent
Riverstone Resources Sdn Bhd
Kawasan Perindustrian Bukit
48300 Bukit Beruntung
Selangor,  MY
Correspondent Contact CHONG CHU MEE
Regulation Number880.6250
Classification Product Code
LYY  
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
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