Halyard Purple Xtra And Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate

Polymer Patient Examination Glove

O & M Haylard, Inc.

The following data is part of a premarket notification filed by O & M Haylard, Inc. with the FDA for Halyard Purple Xtra And Purple Sterile, Low Dermatitis Potential, Powder-free Exam Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.

Pre-market Notification Details

Device IDK192241
510k NumberK192241
Device Name:Halyard Purple Xtra And Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate
ClassificationPolymer Patient Examination Glove
Applicant O & M Haylard, Inc. 5405 Windward Parkway Alpharetta,  GA  30004
ContactSteven Dowdley
CorrespondentSteven Dowdley
O & M Haylard, Inc. 5405 Windward Parkway Alpharetta,  GA  30004
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2020-03-13

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