Medical Device Manufacturer · MY , Klang

Kossan International Sdn Bhd

12 submissions · 12 cleared · Since 2015
12
Total
12
Cleared
0
Denied

Kossan International Sdn Bhd — FDA 510(k) Submissions

Kossan International Sdn Bhd has submitted 12 FDA 510(k) premarket notifications since 2015, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Polymer Patient Examination Glove, Latex Patient Examination Glove . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
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
K252549 · LZA Polymer Patient... · General Hospital
Jan 2026 153d
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
K232461 · LZA Polymer Patient... · General Hospital
Nov 2023 91d
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)
K230573 · LYY Latex Patient Examination... · General Hospital
Jun 2023 104d
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
K191800 · LZA Polymer Patient... · General Hospital
Sep 2019 75d
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K190606 · LZA Polymer Patient... · General Hospital
May 2019 81d
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K183287 · LZA Polymer Patient... · General Hospital
Apr 2019 130d
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K181857 · LZA Polymer Patient... · General Hospital
Nov 2018 132d
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs
K170397 · LZA Polymer Patient... · General Hospital
Jul 2017 151d
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile
K151750 · LZA Polymer Patient... · General Hospital
Aug 2016 401d
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
K151824 · LZA Polymer Patient... · General Hospital
Aug 2016 393d
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
K160467 · LZA Polymer Patient... · General Hospital
Aug 2016 165d
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K143131 · LZA Polymer Patient... · General Hospital
Feb 2015 104d
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