POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929

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 Exam Gloves W/polysil-dc929.

Pre-market Notification Details

Device IDK936063
510k NumberK936063
Device Name:POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929
ClassificationLatex Patient Examination Glove
Applicant HARTALEGA SDN BHD HOUSE OF REPRESENTATIVES 125 CANNON BUILDING Washington,  DC  20515
ContactHoward Winkler
CorrespondentHoward Winkler
HARTALEGA SDN BHD HOUSE OF REPRESENTATIVES 125 CANNON BUILDING Washington,  DC  20515
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-20
Decision Date1994-06-06

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