Signature Latex And Signature Latex Micro, Powder-Free, Surgical Glove, Tested For Use With Chemotherapy Drugs With A Protein Content Label Claim Of

Surgeon's Gloves

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Signature Latex And Signature Latex Micro, Powder-free, Surgical Glove, Tested For Use With Chemotherapy Drugs With A Protein Content Label Claim Of.

Pre-market Notification Details

Device IDK202668
510k NumberK202668
Device Name:Signature Latex And Signature Latex Micro, Powder-Free, Surgical Glove, Tested For Use With Chemotherapy Drugs With A Protein Content Label Claim Of
ClassificationSurgeon's Gloves
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactJennifer Mason
CorrespondentJennifer Mason
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-14
Decision Date2020-12-19

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