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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 K003232
Device Name RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
Applicant
Riverstone Resources Sdn Bhd
Lot 21909, #5, Lorong Helan
Hindik Kepong Baru Indust. Est
Kepong Baru, Kuala Lumpur,  MY 52100
Applicant Contact CHONG CHU MEE
Correspondent
Riverstone Resources Sdn Bhd
Lot 21909, #5, Lorong Helan
Hindik Kepong Baru Indust. Est
Kepong Baru, Kuala Lumpur,  MY 52100
Correspondent Contact CHONG CHU MEE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/17/2000
Decision Date 10/26/2000
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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