NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR

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, Power Free Nitrile Examination Gloves-orange, Green, Blue And Violet Color.

Pre-market Notification Details

Device IDK143289
510k NumberK143289
Device Name:NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
ClassificationPolymer Patient Examination Glove
Applicant YTY INDUSTRY (MANJUNG) SDN. BHD. LOT 1422-1424, BATU 10 LEKIR Sitiawan, Perak,  MY 32020
ContactArivagalan Subramaniam
CorrespondentPunitha Samy
YTY INDUSTRY (MANJUNG) SDN. BHD. LOT 1422-1424, BATU 10 LEKIR Sitiawan, Perak,  MY 32020
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-17
Decision Date2015-08-18
Summary:summary

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