FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)

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 Flavored Powder Free And Polymer Coated Examination Glove (vanlla, Grape And Strawberry).

Pre-market Notification Details

Device IDK121591
510k NumberK121591
Device Name:FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
ClassificationLatex Patient Examination Glove
Applicant TEKMEDIC (M) SDN BHD PLOT 4, TANJUNG KLING INDUSTRIAL AREA, TANJUNG BRUAS Jetty, Tanjung Kling, Malacca,  MY 76400
ContactPatrick Leong
CorrespondentPatrick Leong
TEKMEDIC (M) SDN BHD PLOT 4, TANJUNG KLING INDUSTRIAL AREA, TANJUNG BRUAS Jetty, Tanjung Kling, Malacca,  MY 76400
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-31
Decision Date2012-10-11

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