Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)

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 Powder Free Nitrile Patient Examination Gloves, Non-sterile (orange).

Pre-market Notification Details

Device IDK192635
510k NumberK192635
Device Name:Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
ClassificationPolymer Patient Examination Glove
Applicant WRP ASIA PACIFIC SDN BHD Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang,  MY 43900
ContactHasnah Abdul Hamid
CorrespondentHasnah Abdul Hamid
WRP ASIA PACIFIC SDN BHD Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang,  MY 43900
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-23
Decision Date2020-01-17

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