POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS

Polymer Patient Examination Glove

MAXTER GLOVE MANUFACTURING SDN BHD

The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK113100
510k NumberK113100
Device Name:POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
ClassificationPolymer Patient Examination Glove
Applicant MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang,  MY 41050
ContactYap P Geeh
CorrespondentYap P Geeh
MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang,  MY 41050
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-19
Decision Date2012-02-06

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