MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE

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 Powder-free Nitrile Examination Glove With Aloe.

Pre-market Notification Details

Device IDK081594
510k NumberK081594
Device Name:MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
ClassificationPolymer Patient Examination Glove
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-06
Decision Date2008-10-17

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