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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 K260794
Device Name NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
Applicant
Kossan International Sdn Bhd
Kossan Tower # 6d, Persiaran Setia Dagang, Setia Alam, Seksy
Shah Alam,  MY 40170
Applicant Contact Cho Sow Fong
Correspondent
Kossan International Sdn Bhd
Kossan Tower # 6d, Persiaran Setia Dagang, Setia Alam, Seksy
Shah Alam,  MY 40170
Correspondent Contact Cho Sow Fong
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received03/11/2026
Decision Date 08/18/2026
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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