SCIPOTEX/POWDER FREE EXAMINATION GLOVES

Latex Patient Examination Glove

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Scipotex/powder Free Examination Gloves.

Pre-market Notification Details

Device IDK951668
510k NumberK951668
Device Name:SCIPOTEX/POWDER FREE EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor,  MY 43900
ContactOng G Chee
CorrespondentOng G Chee
WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor,  MY 43900
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-10
Decision Date1995-05-17

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