Kossan International Sdn Bhd is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Kossan International Sdn Bhd - FDA 510(k) Cleared Devices
Recent clearances: 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, Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, 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)
12
Total
12
Cleared
0
Denied
Kossan International Sdn Bhd has 12 FDA 510(k) cleared general hospital devices. Based in Klang, MY.
Latest FDA clearance: Jan 2026. Active since 2015.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Kossan International Sdn Bhd
12 devices
Cleared
Jan 13, 2026
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green),...
General Hospital
153d
Cleared
Nov 14, 2023
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for...
General Hospital
91d
Cleared
Jun 13, 2023
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with...
General Hospital
104d
Cleared
Sep 16, 2019
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with...
General Hospital
75d
Cleared
May 28, 2019
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
General Hospital
81d
Cleared
Apr 05, 2019
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile,...
General Hospital
130d
Cleared
Nov 20, 2018
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low...
General Hospital
132d
Cleared
Jul 10, 2017
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile,...
General Hospital
151d
Cleared
Aug 03, 2016
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile,...
General Hospital
401d
Cleared
Aug 02, 2016
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low...
General Hospital
393d
Cleared
Aug 02, 2016
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use...
General Hospital
165d
Cleared
Feb 12, 2015
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
General Hospital
104d