QUALATEX POWDERED LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

TAN SIN LIAN INDUSTRIES SDN. BHD.

The following data is part of a premarket notification filed by Tan Sin Lian Industries Sdn. Bhd. with the FDA for Qualatex Powdered Latex Examination Gloves.

Pre-market Notification Details

Device IDK992557
510k NumberK992557
Device Name:QUALATEX POWDERED LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant TAN SIN LIAN INDUSTRIES SDN. BHD. NO. 8, TAMAN MARIN JALAN HAJI ABDULLAH Muar, Johor,  MY 84000
ContactTan Tiow Gin
CorrespondentTan Tiow Gin
TAN SIN LIAN INDUSTRIES SDN. BHD. NO. 8, TAMAN MARIN JALAN HAJI ABDULLAH Muar, Johor,  MY 84000
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-30
Decision Date1999-09-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09555697505105 K992557 000
09555697505099 K992557 000
09555697505082 K992557 000
09555697505075 K992557 000
09555697505068 K992557 000

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