DERMAGRIP POWDER FREE BLACK NITRILE PATIENT 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 Powder Free Black Nitrile Patient Examination Gloves, Non-sterile.

Pre-market Notification Details

Device IDK132484
510k NumberK132484
Device Name:DERMAGRIP POWDER FREE BLACK NITRILE PATIENT 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
ContactKirk Penner
CorrespondentKirk Penner
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 Received2013-08-08
Decision Date2013-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30851253007992 K132484 000
30851253007985 K132484 000
30851253007978 K132484 000
30851253007961 K132484 000

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