Medline Nitrile Powder-Free Examination Glove With Colloidal Oatmeal USP (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 Nitrile Powder-free Examination Glove With Colloidal Oatmeal Usp (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK162982
510k NumberK162982
Device Name:Medline Nitrile Powder-Free Examination Glove With Colloidal Oatmeal USP (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer 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 CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-26
Decision Date2017-02-27
Summary:summary

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