UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES

Polymer Patient Examination Glove

N.S. UNI-GLOVES SDN. BHD.

The following data is part of a premarket notification filed by N.s. Uni-gloves Sdn. Bhd. with the FDA for Uniglove Nitrile Powder-free Examination Gloves.

Pre-market Notification Details

Device IDK000689
510k NumberK000689
Device Name:UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant N.S. UNI-GLOVES SDN. BHD. UG HEALTHCARE (USA) INC 2420 CARSON ST. SUITE 125 Torrance,  CA  90501
ContactRobert D Vander Leek
CorrespondentRobert D Vander Leek
N.S. UNI-GLOVES SDN. BHD. UG HEALTHCARE (USA) INC 2420 CARSON ST. SUITE 125 Torrance,  CA  90501
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-29
Decision Date2000-04-28

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