Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use With Chemotherapy Drugs)

Polymer Patient Examination Glove

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Sterile Powder-free Nitrile Examination Gloves - Green (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK191753
510k NumberK191753
Device Name:Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer Patient Examination Glove
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactClaire Pigman
CorrespondentClaire Pigman
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeLZA  
Subsequent Product CodeLYA
Subsequent Product CodeLYZ
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-01
Decision Date2020-03-17

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.