Nitrile Blue Powder-free Examination Glove

Polymer Patient Examination Glove

Cardinal Health 200, LLC

The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Nitrile Blue Powder-free Examination Glove.

Pre-market Notification Details

Device IDK211390
510k NumberK211390
Device Name:Nitrile Blue Powder-free Examination Glove
ClassificationPolymer Patient Examination Glove
Applicant Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan,  IL  60085
ContactWilliam Cisneros
CorrespondentWilliam Cisneros
Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan,  IL  60085
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-05
Decision Date2021-08-28

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