MAXTER STERILE POWDER FREE SURGICAL GLOVES

Surgeon's Gloves

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 Sterile Powder Free Surgical Gloves.

Pre-market Notification Details

Device IDK032501
510k NumberK032501
Device Name:MAXTER STERILE POWDER FREE SURGICAL GLOVES
ClassificationSurgeon's Gloves
Applicant MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, Selangor,  MY 41050
ContactStanley Thai
CorrespondentStanley Thai
MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, Selangor,  MY 41050
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-13
Decision Date2003-10-17

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