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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 K230875
Device Name Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
Applicant
Central Medicare Sdn Bhd
Pt 2609 - 2620, Batu 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Applicant Contact Chua Kah Ying
Correspondent
Central Medicare Sdn Bhd
Pt 2609 - 2620, Batu 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Correspondent Contact Chua Kah Ying
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received03/30/2023
Decision Date 07/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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