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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 K231021
Device Name KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Applicant
Kimberly-Clark Corporation
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Applicant Contact Kimberly Tempas
Correspondent
Pathmaker FDA Law, PLLC
1415 Lilac Dr. N; Suite 270
Minneapolis,  MN  55422
Correspondent Contact Amy Fowler
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received04/10/2023
Decision Date 07/21/2023
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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