MAXTER STERILE POWDERED LATEX 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 Powdered Latex Surgical Gloves.

Pre-market Notification Details

Device IDK032467
510k NumberK032467
Device Name:MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
ClassificationSurgeon's Gloves
Applicant MAXTER GLOVE MANUFACTURING SDN BHD 6TH MILES OFF JALAN MERU Klang Selangor,  MY 41050
ContactPriscilla Wee
CorrespondentPriscilla Wee
MAXTER GLOVE MANUFACTURING SDN BHD 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 Received2003-08-11
Decision Date2003-10-10

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