NITRILE LATEX POWDERED EXAMINATION GLOVE

Polymer 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 Nitrile Latex Powdered Examination Glove.

Pre-market Notification Details

Device IDK983816
510k NumberK983816
Device Name:NITRILE LATEX POWDERED EXAMINATION GLOVE
ClassificationPolymer Patient Examination Glove
Applicant TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan,  MY
ContactT.s. Puon
CorrespondentT.s. Puon
TOP GLOVE SDN. BHD. 41050 KLANG,SELANGOR Darul Ehsan,  MY
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-29
Decision Date1998-12-04

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