Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)

Patient Examination Glove, Specialty

Medline Industires, Inc.

The following data is part of a premarket notification filed by Medline Industires, Inc. with the FDA for Medline Powder-free Light Blue Nitrile Exam Gloves (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK201390
510k NumberK201390
Device Name:Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
ClassificationPatient Examination Glove, Specialty
Applicant Medline Industires, Inc. Three Lakes Drive Northfield,  IL  60093
ContactAdam Ostrower
CorrespondentAdam Ostrower
Medline Industires, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeLZC  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-27
Decision Date2020-09-18

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