Medline Glide-On 3G Vinyl Examination Gloves

Vinyl 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 Glide-on 3g Vinyl Examination Gloves.

Pre-market Notification Details

Device IDK192985
510k NumberK192985
Device Name:Medline Glide-On 3G Vinyl Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactStephanie Augsburg
CorrespondentStephanie Augsburg
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-25
Decision Date2020-01-21

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