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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 K240266
Device Name Latex Examination Glove Powder Free (Ocean Blue and Natural White)
Applicant
Sri Trang Gloves (Thailand) Public Company Limited
110 Kanjanavanit Rd.
Hatyai,  TH 90230
Applicant Contact M. Jordan Smith
Correspondent
Sri Trang Gloves (Thailand) Public Company Limited
110 Kanjanavanit Rd.
Hatyai,  TH 90230
Correspondent Contact M. Jordan Smith
Regulation Number880.6250
Classification Product Code
LYY  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received01/31/2024
Decision Date 09/09/2024
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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