Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla

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 Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla.

Pre-market Notification Details

Device IDK143055
510k NumberK143055
Device Name:Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla
ClassificationPolymer Patient Examination Glove
Applicant YTY INDUSTRY (MANJUNG) SDN. BHD. LOT 1422-1424, BATU 10 LEKIR Sitiawan,  MY 32020
ContactArivalagan Subramaniam
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 Received2014-10-23
Decision Date2015-02-12
Summary:summary

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