SCIPOTEX POWDER FREE EXAM GLOVES (BEADED)

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 Exam Gloves (beaded).

Pre-market Notification Details

Device IDK942511
510k NumberK942511
Device Name:SCIPOTEX POWDER FREE EXAM GLOVES (BEADED)
ClassificationLatex Patient Examination Glove
Applicant WEMBLEY RUBBER PRODUCTS (M) SDN BHD 84, JALAN RAJA CHULAN 50200 KUALA LUMPUR Malaysia,  MY
ContactOng Ghee Chee
CorrespondentOng Ghee Chee
WEMBLEY RUBBER PRODUCTS (M) SDN BHD 84, JALAN RAJA CHULAN 50200 KUALA LUMPUR Malaysia,  MY
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-26
Decision Date1995-02-03

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