COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE

Polymer Patient Examination Glove

WRP ASIA PACIFIC SDN. BHD.

The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Comfit Powder Free Nitrile Examination Glove, Sterile.

Pre-market Notification Details

Device IDK993311
510k NumberK993311
Device Name:COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
ClassificationPolymer Patient Examination Glove
Applicant WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor,  MY 43900
ContactYue Wah Chow
CorrespondentYue Wah Chow
WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor,  MY 43900
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-04
Decision Date1999-11-19
Summary:summary

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