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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 K002314
Device Name LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR
Applicant
PERUSAHAAN GETAH ASAS SDN BHD
LOT 754, JALAN HAJI SIRAT
SELANGOR,  MY 41720
Applicant Contact TAN KONG CHANG
Correspondent
PERUSAHAAN GETAH ASAS SDN BHD
LOT 754, JALAN HAJI SIRAT
SELANGOR,  MY 41720
Correspondent Contact TAN KONG CHANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/31/2000
Decision Date 08/17/2000
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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