Blue Nitrile Powder Free Patient Examination Glove, Non Sterile

Polymer Patient Examination Glove

Onetexx SDN BHD

The following data is part of a premarket notification filed by Onetexx Sdn Bhd with the FDA for Blue Nitrile Powder Free Patient Examination Glove, Non Sterile.

Pre-market Notification Details

Device IDK210366
510k NumberK210366
Device Name:Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
ClassificationPolymer Patient Examination Glove
Applicant Onetexx SDN BHD No 73-86, Jalan Logam 5, Perindustrian Kamunting 3, Kamunting Raya Industrial Estate Kamunting,  MY 34600
ContactFreddy Low
CorrespondentMichael Van Der Woude
Emergo Global Representation 2500 Bee Cave Road, Building 1 Suite 300 Austin,  TX  78746
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2021-05-07

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