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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 K191800
Device Name Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, 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  
Date Received07/03/2019
Decision Date 09/16/2019
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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