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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 K223748
Device Name Nitrile Exam Gloves (Chemotherapy Drug Tested)
Applicant
US Medical Glove Company LLC
325 South Illinois Route 31, Building G
Montgomery,  IL  60538
Applicant Contact Jorge A. Alcazar
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ  
Date Received12/14/2022
Decision Date 01/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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