Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves With Colloidal Oatmeal (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 Green Ambidextrous Powder-free Nitrile Examination Gloves With Colloidal Oatmeal (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK180696
510k NumberK180696
Device Name:Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves With Colloidal Oatmeal (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer Patient Examination Glove
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactPauline Maralit
CorrespondentPauline Maralit
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-16
Decision Date2018-04-30
Summary:summary

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