SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES

Polymer 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 Scinitrex Power Free Blue Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK952154
510k NumberK952154
Device Name:SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES
ClassificationPolymer 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 CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-08
Decision Date1995-12-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.