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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K201390
Device Name Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
Applicant
Medline Industires, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Applicant Contact Adam Ostrower
Correspondent
Medline Industires, Inc.
Three Lakes Dr.
Nortfield,  IL  60093
Correspondent Contact Adam Ostrower
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received05/27/2020
Decision Date 09/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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