NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)

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 Gloves (white).

Pre-market Notification Details

Device IDK050214
510k NumberK050214
Device Name:NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
ClassificationPolymer Patient Examination Glove
Applicant HARTALEGA SDN BHD LOT 9, JALAN KUANG BULAN,TAMAN KEPONG IND. ESTATE Selangor, Darul Ehsan,  MY 52100
ContactKuan Eu Jin
CorrespondentKuan Eu Jin
HARTALEGA SDN BHD LOT 9, JALAN KUANG BULAN,TAMAN KEPONG IND. ESTATE Selangor, Darul Ehsan,  MY 52100
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-31
Decision Date2005-03-16

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