LATEX EXAMINATION GLOVES, POWDER FREE

Latex Patient Examination Glove

TEKMEDIC (M) SDN BHD

The following data is part of a premarket notification filed by Tekmedic (m) Sdn Bhd with the FDA for Latex Examination Gloves, Powder Free.

Pre-market Notification Details

Device IDK930602
510k NumberK930602
Device Name:LATEX EXAMINATION GLOVES, POWDER FREE
ClassificationLatex Patient Examination Glove
Applicant TEKMEDIC (M) SDN BHD C/O CAL-AMERICAN MEDICAL SUPPL 2651 MANHATTAN BEACH BOULEVARD Redondo Beach,  CA  90278
ContactWallace Wong
CorrespondentWallace Wong
TEKMEDIC (M) SDN BHD C/O CAL-AMERICAN MEDICAL SUPPL 2651 MANHATTAN BEACH BOULEVARD Redondo Beach,  CA  90278
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-02
Decision Date1993-09-29

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