Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves

Patient Examination Glove, Specialty

O & M Halyard, Inc.

The following data is part of a premarket notification filed by O & M Halyard, Inc. with the FDA for Halyard Sterling* Nitrile Powder-free Exam Gloves, Halyard Sterling Sg* Nitrile Sensi-guard Powder-free Exam Gloves.

Pre-market Notification Details

Device IDK191230
501k NumberK191230
Device Name:Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
ClassificationPatient Examination Glove, Specialty
Applicant O & M Halyard, Inc. 9120 Lockwood Blvd Mechanicsville,  VA  23116
ContactSteve Dowdlley
CorrespondentSteve Dowdlley
O & M Halyard, Inc. 9120 Lockwood Blvd Mechanicsville,  VA  23116
Product CodeLZC  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
501k Review PanelGeneral Hospital
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-08
Decision Date2019-11-08

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.