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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 K192315
Device Name Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (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 Codes
LZC   OPJ  
Date Received08/26/2019
Decision Date 01/10/2020
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
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