SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE

Vinyl Patient Examination Glove

TOP GLOVE SDN. BHD.

The following data is part of a premarket notification filed by Top Glove Sdn. Bhd. with the FDA for Synthetic Vinyl Medical Examination Powder Free Glove.

Pre-market Notification Details

Device IDK993680
510k NumberK993680
Device Name:SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
ClassificationVinyl Patient Examination Glove
Applicant TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan,  MY
ContactWee-chai Lim
CorrespondentWee-chai Lim
TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan,  MY
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-01
Decision Date1999-12-13

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