POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR

Polymer Patient Examination Glove

HL RUBBER INDUSTRIES SDN BHD

The following data is part of a premarket notification filed by Hl Rubber Industries Sdn Bhd with the FDA for Powder-free Nitrile Examination Gloves, Orange, Color.

Pre-market Notification Details

Device IDK141021
510k NumberK141021
Device Name:POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
ClassificationPolymer Patient Examination Glove
Applicant HL RUBBER INDUSTRIES SDN BHD LOT 10, KAWASAN PERINDUSTRIAN DIOH Kuala Pilah, Negeri Sembilan,  MY 72000
ContactNoorzaliza Ahmad
CorrespondentNoorzaliza Ahmad
HL RUBBER INDUSTRIES SDN BHD LOT 10, KAWASAN PERINDUSTRIAN DIOH Kuala Pilah, Negeri Sembilan,  MY 72000
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-21
Decision Date2014-08-26

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