DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-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 Dermagrip-n/multiple/wrp Asia Pacific Sdn Bhd Powder Free Nitrile Examination Gloves, Non-sterile.

Pre-market Notification Details

Device IDK022904
510k NumberK022904
Device Name:DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-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 Received2002-09-03
Decision Date2002-10-03
Summary:summary

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