Chrysalis Intelligence · Sponsors · Kossan International Sdn Bhd

Kossan International Sdn Bhd

Klang, MY · 4 510(k) clearances

Total clearances
4
2023-06-13 → 2026-08-18
Last 12 months
2
Product codes
2
Most recent
2026-08-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LZA Polymer Patient Examination Glove Class I General Hospital 3 2026-08-18
LYY Latex Patient Examination Glove Class I General Hospital 1 2023-06-13
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2026-08-18 K260794 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 LZA Class I General Hospital
2026-01-13 K252549 Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid LZA Class I General Hospital
2023-11-14 K232461 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 LZA Class I General Hospital
2023-06-13 K230573 Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) LYY Class I General Hospital