Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (Blue)

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 Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (blue).

Pre-market Notification Details

Device IDK150593
510k NumberK150593
Device Name:Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (Blue)
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA SDN BHD C-G-1 JALAN DATARAN SD1 DATARAN SD PJU 9 Bandar Sri Damansara,  MY 52200
ContactKuan Kam Hon
CorrespondentNurul Aisyah Kong
HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, Selangor,  MY 45600
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-09
Decision Date2015-06-09

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