HALYARD Flexaprene Green Powder-Free Exam Glove

Polymer Patient Examination Glove

O & M Halyard, Inc.

The following data is part of a premarket notification filed by O & M Halyard, Inc. with the FDA for Halyard Flexaprene Green Powder-free Exam Glove.

Pre-market Notification Details

Device IDK211063
510k NumberK211063
Device Name:HALYARD Flexaprene Green Powder-Free Exam Glove
ClassificationPolymer Patient Examination Glove
Applicant O & M Halyard, Inc. 1 Edison Drive Alpharetta,  GA  30005
ContactSteven Dowdley
CorrespondentSteven Dowdley
O & M Halyard, Inc. 1 Edison Drive Alpharetta,  GA  30005
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-09
Decision Date2021-11-19

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