BLUE POWDER FREE NITRILE EXAMINATION GLOVES

Polymer Patient Examination Glove

HARTALEGA SDN BHD

The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Blue Powder Free Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK052583
510k NumberK052583
Device Name:BLUE POWDER FREE NITRILE EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur,  MY 52100
ContactKuan Kam Hon
CorrespondentKuan Kam Hon
HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur,  MY 52100
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-20
Decision Date2006-06-14

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