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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 K160467
Device Name Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
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  
Subsequent Product Code
LZC  
Date Received02/19/2016
Decision Date 08/02/2016
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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