Glide-On 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 Glide-on Vinyl Examination Gloves.

Pre-market Notification Details

Device IDK151754
510k NumberK151754
Device Name:Glide-On Vinyl Examination Gloves
ClassificationVinyl Patient Examination Glove
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactJennifer Mason
CorrespondentJennifer Mason
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-29
Decision Date2016-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40080196167976 K151754 000

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