Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile

Polymer Patient Examination Glove

One Glove Industrial Sdn Bhd

The following data is part of a premarket notification filed by One Glove Industrial Sdn Bhd with the FDA for Blue Nitrile Powder-free Patient Examination Glove, Non-sterile.

Pre-market Notification Details

Device IDK220431
510k NumberK220431
Device Name:Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
ClassificationPolymer Patient Examination Glove
Applicant One Glove Industrial Sdn Bhd 24, 1st Floor, Kompleks Kota Mulia, Jalan Long Jaafar, Taiping,  MY 34000
ContactMarcus Low
CorrespondentMichael Van Der Woude
Emergo Global Representative LLC 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 Received2022-02-15
Decision Date2022-06-17

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