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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 K232764
Device Name Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant
Eco Medi Glove Sdn. Bhd.
Lot 23826, Jalan Tembaga Kuning
Kamunting Raya Industrial Estate
Taiping,  MY 34600
Applicant Contact Suresh Kumar
Correspondent
Eco Medi Glove Sdn. Bhd.
Lot 23826, Jalan Tembaga Kuning
Kamunting Raya Industrial Estate
Taiping,  MY 34600
Correspondent Contact Suresh Kumar
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received09/08/2023
Decision Date 02/07/2024
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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