POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL

Polymer Patient Examination Glove

KOSSAN LATEX INDUSTRIES(M)SDN BHD

The following data is part of a premarket notification filed by Kossan Latex Industries(m)sdn Bhd with the FDA for Powder Free Nitrile Patient Examination Glove, Blue, White And Green Colored. Non-sterile, Low Dermatitis Potential.

Pre-market Notification Details

Device IDK120066
510k NumberK120066
Device Name:POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
ClassificationPolymer Patient Examination Glove
Applicant KOSSAN LATEX INDUSTRIES(M)SDN BHD LOT 6129,JALAN HAJI ABDUL MANAN, OFF JALAN MERU Klang, Selangor D.e.,  MY 41050
ContactCho S Fong
CorrespondentCho S Fong
KOSSAN LATEX INDUSTRIES(M)SDN BHD LOT 6129,JALAN HAJI ABDUL MANAN, OFF JALAN MERU Klang, Selangor D.e.,  MY 41050
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-09
Decision Date2012-11-16
Summary:summary

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