Kossan International Sdn Bhd

FDA Regulatory Profile

Kossan International Sdn Bhd appears in FDA public data with 0 recalls, 13 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Aug 18, 2026.

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESAug 18, 2026
K252549Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with CheJan 13, 2026
K232461Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy DNov 14, 2023
K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeliJun 13, 2023
K191800Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, SterSep 16, 2019
K190606Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileMay 28, 2019
K183287Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with ChemotApr 5, 2019
K181857Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Nov 20, 2018
K170397Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested forJul 10, 2017
K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile PatienAug 3, 2016
K160467Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy DrugsAug 2, 2016
K151824Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, Aug 2, 2016
K143131Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileFeb 12, 2015