PATIENT 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 Patient Examination Gloves.

Pre-market Notification Details

Device IDK945885
510k NumberK945885
Device Name:PATIENT EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur,  MY 52100
ContactKuan K Hon
CorrespondentKuan K Hon
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 Received1994-12-01
Decision Date1995-03-23

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