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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 K992558
Device Name NITRILE PATIENT EXAMINATION GLOVES, POWDERED, 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 C.M. CHONG
Correspondent
Riverstone Resources Sdn Bhd
Lot 21909, #5, Lorong Helan
Hindik Kepong Baru Indust. Est
Kepong Baru, Kuala Lumpur,  MY 52100
Correspondent Contact C.M. CHONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/30/1999
Decision Date 09/27/1999
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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