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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 K990963
Device Name RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
Applicant
Riverstone Resources Sdn Bhd
5, Lorong Helang Hindik
Kepong Baru Industrial Estate
Kuala Lumpar,  MY 52100
Applicant Contact CHU MEE CHONG
Correspondent
Riverstone Resources Sdn Bhd
5, Lorong Helang Hindik
Kepong Baru Industrial Estate
Kuala Lumpar,  MY 52100
Correspondent Contact CHU MEE CHONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/23/1999
Decision Date 05/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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