Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs-Violet Blue (VBLU)

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 Gloves Tested For Use With Chemotherapy Drugs-violet Blue (vblu).

Pre-market Notification Details

Device IDK151997
510k NumberK151997
Device Name:Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs-Violet Blue (VBLU)
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA NGC SDN BHD NO. 1, PERSIARAN TANJUNG, LOT PT4330 KAWASAN PERINDUSTRIAN TANJUNG, JALAN B20 Sepang,  MY 64000
ContactKuan Mun Leong
CorrespondentNurul Aisyah Kong
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 Received2015-07-20
Decision Date2016-03-31

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