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

Pre-market Notification Details

Device IDK192232
501k NumberK192232
Device Name:Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (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
Hartalega NGC Sdn. Bhd. No. 1, Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang,  MY 43900
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
501k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-16
Decision Date2019-11-08

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