Black 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 Black Nitrile Powder Free Patient Examination Glove, Non Sterile.

Pre-market Notification Details

Device IDK210588
510k NumberK210588
Device Name:Black 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
CorrespondentWava Truscott
Onetexx Sdn Bhd 189 Burkemeade Ct. Roswell,  GA  30075
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-26
Decision Date2021-10-31

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