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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K191753
Device Name Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)
Applicant
Medline Industries, Inc.
Three Lakes Drive
Northfield,  IL  60093
Applicant Contact Claire Pigman
Correspondent
Medline Industries, Inc.
Three Lakes Drive
Northfield,  IL  60093
Correspondent Contact Claire Pigman
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received07/01/2019
Decision Date 03/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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