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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 K143131
Device Name Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
Applicant
Kossan International Sdn Bhd
Wisma Kossan, Lot 782, Jalan Sungai Putus, Off Batu 3 3/4,
Jalan Kapar
Klang,  MY 42100
Applicant Contact Cho Sow Fong
Correspondent
Kossan International Sdn Bhd
Wisma Kossan, Lot 782, Jalan Sungai Putus, Off Batu 3 3/4,
Jalan Kapar
Klang,  MY 42100
Correspondent Contact Cho Sow Fong
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/31/2014
Decision Date 02/12/2015
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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