LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING

Latex 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 Latex Examination Glove W/ Low Protein Labeling.

Pre-market Notification Details

Device IDK990468
510k NumberK990468
Device Name:LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
ClassificationLatex Patient Examination Glove
Applicant TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan,  MY
ContactLim Wee Chai
CorrespondentLim Wee Chai
TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan,  MY
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-16
Decision Date1999-04-27

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