NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC

Polymer Patient Examination Glove

YTY Industry (Manjung) Sdn Bhd

The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn Bhd with the FDA for Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested For Use With Chemotherapy Drugs Blue-ac.

Pre-market Notification Details

Device IDK200453
510k NumberK200453
Device Name:NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC
ClassificationPolymer Patient Examination Glove
Applicant YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir Sitiawan,  MY 32020
ContactPunitha Samy
CorrespondentPunitha Samy
YTY Industry (Manjung) Sdn Bhd Lot 1422-1424, Batu 10 Lekir Sitiawan,  MY 32020
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-24
Decision Date2020-05-01

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