SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested For Use With Chemotherapy Drugs)

Surgeon's Gloves

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Sensicare Neoprene Synthetic Polychloroprene Surgical Glove (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK192820
510k NumberK192820
Device Name:SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested For Use With Chemotherapy Drugs)
ClassificationSurgeon's Gloves
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactMatt Clausen
CorrespondentMatt Clausen
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-02-28

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