POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

HARTALEGA SDN BHD

The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Polymer Coated Powder-free Latex Examination Gloves.

Pre-market Notification Details

Device IDK973778
510k NumberK973778
Device Name:POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur,  MY 52100
ContactKam H Kuan
CorrespondentKam H Kuan
HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur,  MY 52100
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-03
Decision Date1997-12-11

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