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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K201829
Device Name SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
Applicant
Medline Industries, Inc.
Three Lakes Drive
Northfield,  IL  60030
Applicant Contact Jennifer Mason
Correspondent
Medline Industries, Inc.
Three Lakes Drive
Northfield,  IL  60030
Correspondent Contact Jennifer Mason
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received07/02/2020
Decision Date 09/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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