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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 K234097
Device Name Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant
Ever Growth (Vietnam) Corporation Limited
Long Khanh Industrial Zone,
Binh Loc Commune,
Long Khanh City,  VN 76461
Applicant Contact Deng Elizabeth
Correspondent
Ever Growth (Vietnam) Corporation Limited
Long Khanh Industrial Zone,
Binh Loc Commune,
Long Khanh City,  VN 76461
Correspondent Contact Deng Elizabeth
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received12/26/2023
Decision Date 03/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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