POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS

Polymer Patient Examination Glove

TOP CALIBRE SDN BHD

The following data is part of a premarket notification filed by Top Calibre Sdn Bhd with the FDA for Powder Free Nitrile Patient Examination Glove,blue And Orange Colored,non-sterile Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK133949
510k NumberK133949
Device Name:POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
ClassificationPolymer Patient Examination Glove
Applicant TOP CALIBRE SDN BHD Lot 13726, Jalan Haji Salleh, Batu 5 1/4 Off Jalan Meru Klang, Selangor,  MY 41050
ContactRosnita Maodin
CorrespondentRosnita Maodin
TOP CALIBRE SDN BHD Lot 13726, Jalan Haji Salleh, Batu 5 1/4 Off Jalan Meru Klang, Selangor,  MY 41050
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-23
Decision Date2014-04-08
Summary:summary

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