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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 K232461
Device Name Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis
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 Codes
LZC   OPJ   QDO  
Date Received08/15/2023
Decision Date 11/14/2023
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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