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

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 Lavender, Low Dermatitis Potential, Powder-free Exam Gloves Tested For Use With Chemotherapy Drugs And And Fentanyl Citrate.

Pre-market Notification Details

Device IDK202622
510k NumberK202622
Device Name:Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And And Fentanyl Citrate
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  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-10
Decision Date2021-01-07

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.