COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)

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 Comfit Pink Powdered Examination Gloves (hypoallergenic).

Pre-market Notification Details

Device IDK936266
510k NumberK936266
Device Name:COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
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 Received1993-12-30
Decision Date1995-04-13

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