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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 K182308
Device Name Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
Applicant
Sri Trang Gloves (Thailand) Co., Ltd.
10 Soi 10 Phetkasem Rd.
Hatyai,  TH 90110
Applicant Contact Anan Pruksanusak
Correspondent
Sri Trang USA Dba Ventyv
5401 W. Kennedy Blvd., Suite 760
Tampa,  FL  33609
Correspondent Contact M. Jordan Smith
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received08/24/2018
Decision Date 05/30/2019
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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