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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 K210944
Device Name Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
Applicant
Harbour Health, LLC
4590 Macarthur Blvd., Suite 500
Newport Beach,  CA  92660
Applicant Contact Jared Koenig
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ  
Date Received03/30/2021
Decision Date 04/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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