MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES

Polymer Patient Examination Glove

MAXTER GLOVE MANUFACTURING SDN BHD

The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Maxter Powder Free Nitrile Medical Examination Gloves.

Pre-market Notification Details

Device IDK040176
510k NumberK040176
Device Name:MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, Selangor,  MY 41050
ContactPriscilla Wee
CorrespondentPriscilla Wee
MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, Selangor,  MY 41050
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-26
Decision Date2004-02-24

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