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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 K232654
Device Name Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
Applicant
Nephron Nitrile, LLC
4777 12th St. Extension
West Columbia,  SC  29172
Applicant Contact Lou Kennedy
Correspondent
Nephron Nitrile, LLC
4777 12th St. Extension
West Columbia,  SC  29172
Correspondent Contact Edmundo M. Garcia
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received08/31/2023
Decision Date 03/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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