Kossan International Sdn Bhd

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252549Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with CheJanuary 13, 2026
K232461Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy DNovember 14, 2023
K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeliJune 13, 2023
K191800Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, SterSeptember 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 ChemotApril 5, 2019
K181857Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. November 20, 2018
K170397Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested forJuly 10, 2017
K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile PatienAugust 3, 2016
K160467Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy DrugsAugust 2, 2016
K151824Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, August 2, 2016
K143131Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileFebruary 12, 2015