STERILE POWDERED LATEX SURGEON GLOVES

Surgeon's Gloves

SUPERMAX GLOVE MANUFACTURING SDN BHD

The following data is part of a premarket notification filed by Supermax Glove Manufacturing Sdn Bhd with the FDA for Sterile Powdered Latex Surgeon Gloves.

Pre-market Notification Details

Device IDK010198
510k NumberK010198
Device Name:STERILE POWDERED LATEX SURGEON GLOVES
ClassificationSurgeon's Gloves
Applicant SUPERMAX GLOVE MANUFACTURING SDN BHD 47000 SUNGAI BULOH Selangor,  MY
ContactStanley Thai
CorrespondentStanley Thai
SUPERMAX GLOVE MANUFACTURING SDN BHD 47000 SUNGAI BULOH Selangor,  MY
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-01-22
Decision Date2001-02-23

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