POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)

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 Powder-free Latex Examination Gloves With Protein Labeling Claim (green).

Pre-market Notification Details

Device IDK980572
510k NumberK980572
Device Name:POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
ClassificationLatex 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 CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-17
Decision Date1998-03-13

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