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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 K240930
Device Name Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue
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
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received04/04/2024
Decision Date 07/02/2024
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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