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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 K980572
Device Name POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
Applicant
HARTALEGA SDN BHD
9 JALAN KUANG BULAN TAMAN
KEPONG INDUSTRIAL ESTATE
KUALA LUMPUR,  MY 52100
Applicant Contact KUAN KAM HON
Correspondent
HARTALEGA SDN BHD
9 JALAN KUANG BULAN TAMAN
KEPONG INDUSTRIAL ESTATE
KUALA LUMPUR,  MY 52100
Correspondent Contact KUAN KAM HON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/17/1998
Decision Date 03/13/1998
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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