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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 K051778
Device Name NITRILE POWDERED EXAMINATION GLOVES (BLUE)
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
LZA  
Date Received07/01/2005
Decision Date 07/26/2005
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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