POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE

Polymer Patient Examination Glove

WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II

The following data is part of a premarket notification filed by Wear Safe (malaysia) Sdn Bhd - Facility Ii with the FDA for Powder Free Nitrile Patient Examination Glove, Blue And White Colored, Non-sterile.

Pre-market Notification Details

Device IDK123469
510k NumberK123469
Device Name:POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
ClassificationPolymer Patient Examination Glove
Applicant WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II LOT 63616, PT 54924, NO 3, JALAN KORPORAT 7C/KU9 TAMAN PERINDUSTRIAN MERU Mukim Kapar, Klang, Selangor,  MY 42200
ContactAlex Yoong
CorrespondentAlex Yoong
WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II LOT 63616, PT 54924, NO 3, JALAN KORPORAT 7C/KU9 TAMAN PERINDUSTRIAN MERU Mukim Kapar, Klang, Selangor,  MY 42200
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-13
Decision Date2013-02-19
Summary:summary

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