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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K212482
Device Name Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
Applicant
Sri Trang Gloves (Thailand) Public Company Limited
10 Soi 10 Phetkasem Rd.
Hatyai,  TH 90110
Applicant Contact Jarinya Jirokjul
Correspondent
Sri Trang USA, Inc.
5820 W. Cypress St., Suite H
Tampa,  FL  33607 -1785
Correspondent Contact Jordan Smith
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/09/2021
Decision Date 08/09/2022
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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