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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 K244034
Device Name Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
Applicant
Ever Global (Vietnam) Enterprise Corporation
Long Thanh Industrial Zone
Taman Village,  VN 810000
Applicant Contact Elizabeth Deng
Correspondent
Ever Global (Vietnam) Enterprise Corporation
Long Thanh Industrial Zone
Taman Village,  VN 810000
Correspondent Contact Elizabeth Deng
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received12/30/2024
Decision Date 02/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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