SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated With Aloe V

Surgeon's Gloves

Medicine Industries, Inc

The following data is part of a premarket notification filed by Medicine Industries, Inc with the FDA for Sensicare Sterile Power-free Polymer Coated Polyisoprene Sugical Glove, Coated With Aloe V.

Pre-market Notification Details

Device IDK191915
510k NumberK191915
Device Name:SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated With Aloe V
ClassificationSurgeon's Gloves
Applicant Medicine Industries, Inc Three Lake Drive Northfiled,  IL  60093
ContactJenneifer Mason
CorrespondentJenneifer Mason
Medicine Industries, Inc Three Lake Drive Northfiled,  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 Received2019-07-17
Decision Date2020-03-06

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