MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...

Surgeon's Gloves

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Powder-free Latex Surgical Gloves, Sterile, W/ Or W/o Aloe Vera, With Protein Content Labeling Claim....

Pre-market Notification Details

Device IDK111807
510k NumberK111807
Device Name:MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
ClassificationSurgeon's Gloves
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-27
Decision Date2011-08-18

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