SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES

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 Powdered Gloves.

Pre-market Notification Details

Device IDK993664
510k NumberK993664
Device Name:SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
ClassificationVinyl Patient Examination Glove
Applicant TOP GLOVE SDN. BHD. LOT 4968, BT 6, JALAN TERATAI OFF JALAN MERU Klang, Selangor,  MY 41050
ContactWee-chai Lim
CorrespondentWee-chai Lim
TOP GLOVE SDN. BHD. LOT 4968, BT 6, JALAN TERATAI OFF JALAN MERU Klang, Selangor,  MY 41050
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-29
Decision Date2000-01-11

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