Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (White)

Polymer Patient Examination Glove

HARTALEGA NGC SDN. BHD.

The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (white).

Pre-market Notification Details

Device IDK170794
510k NumberK170794
Device Name:Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (White)
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA NGC SDN. BHD. No.1 Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang,  MY 43900
ContactKuan Mun Leong
CorrespondentNurul Aisyah Kong Bt Abdullah
HARTALEGA NGC SDN. BHD. C-G-9 Jalan Dataran SD1 Dataran SD PJU 9 Bandar Sri Damansara,  MY 52200
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-16
Decision Date2017-06-30

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