COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

SUPERMAX SDN BHD

The following data is part of a premarket notification filed by Supermax Sdn Bhd with the FDA for Colored And Flavored Powder Free Latex Examination Gloves.

Pre-market Notification Details

Device IDK993864
510k NumberK993864
Device Name:COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant SUPERMAX SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Pelong, Selangor,  MY 47500
ContactStanley Thai
CorrespondentStanley Thai
SUPERMAX SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Pelong, Selangor,  MY 47500
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-15
Decision Date2000-01-20

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