510(k) Report

FDA applicant

Kossan International Sdn Bhd

Klang, MY13 decisions2015–20260 recalls

FDA records 13 decisions for Kossan International Sdn Bhd (Klang, MY) from 2015 to 2026: 13 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 151 days from receipt to decision, against 171 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Kossan International Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2015: 12016: 32017: 12018: 12019: 32023: 22026 (partial year): 2
2015high 3 (2016) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Kossan International Sdn Bhd by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kossan International Sdn Bhd’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LZAPolymer Patient Examination Glove12decisions
  • LYYLatex Patient Examination Glove1decision

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 151 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 171 days; 6 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient…Kossan International Sdn Bhd · 20163cite it
  • K183287Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy…Kossan International Sdn Bhd · 20193cite it
  • K143131Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileKossan International Sdn Bhd · 20151cites it
  • K151824Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and…Kossan International Sdn Bhd · 20161cites it

What has FDA decided for it lately?

  • K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR…Kossan International Sdn Bhd · 2026
  • K252549Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with…Kossan International Sdn Bhd · 2026
  • K232461Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and…Kossan International Sdn Bhd · 2023
  • K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim…Kossan International Sdn Bhd · 2023
  • K191800Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile…Kossan International Sdn Bhd · 2019
  • K190606Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileKossan International Sdn Bhd · 2019
  • K183287Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy…Kossan International Sdn Bhd · 2019
  • K181857Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested…Kossan International Sdn Bhd · 2018

All 13 as Kossan International Sdn Bhd →

Other applicant names beginning “Kossan”

FDA records each applicant name separately; these may or may not be the same firm.

Kossan Latex Industries (M)Sdn Bhd 19Kossan International Sdn Bhd3 1