Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove

Patient Examination Glove, Specialty

0 & M Halyard, Inc

The following data is part of a premarket notification filed by 0 & M Halyard, Inc with the FDA for Halyard Black-fire Powder-free Nitrile Exam Glove, Halyard Purple Powder-free Nitrile Exam Glove.

Pre-market Notification Details

Device IDK200633
510k NumberK200633
Device Name:Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
ClassificationPatient Examination Glove, Specialty
Applicant 0 & M Halyard, Inc 5405 Windward Parkway Alpharetta,  GA  30004
ContactSteven Dowdley
CorrespondentSteven Dowdley
0 & M Halyard, Inc 5405 Windward Parkway Alpharetta,  GA  30004
Product CodeLZC  
Subsequent Product CodeLZA
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-10
Decision Date2020-10-11

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