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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 K232614
Device Name Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
Applicant
Sri Trang Gloves (Thailand) Public Company Limited
10 Soi 10 Phetkasem Rd.
Hatyai,  TH 90110
Applicant Contact Jarinya Jirojkul
Correspondent
Sri Trang USA, Inc.
5820 W. Cypress St., Suite H
Tampa,  FL  33607 -1785
Correspondent Contact M. Jordan Smith
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received08/28/2023
Decision Date 05/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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