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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K172642
Device Name Orange Non Sterile Powder Free Nitrile Examination Gloves
Applicant
Central Medicare Sdn. Bhd.
PT 2609 - 2620, BT 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Applicant Contact Arivalagan Subramaniam
Correspondent
Central Medicare Sdn. Bhd.
PT 2609 - 2620, BT 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Correspondent Contact Arivalagan Subramaniam
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received09/01/2017
Decision Date 11/28/2017
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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