Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue, Cobalt Blue)

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, Tested For Use With Chemotherapy Drugs (blue, Cobalt Blue).

Pre-market Notification Details

Device IDK171104
510k NumberK171104
Device Name:Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue, Cobalt Blue)
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 Received2017-04-13
Decision Date2017-08-25
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.