510(k) Report

FDA applicant

Koon Seng Sdn Bhd

Greenwood Village, CO7 decisions1989–20210 recalls

FDA records 7 decisions for Koon Seng Sdn Bhd (Greenwood Village, CO) from 1989 to 2021: 7 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Its devices cite 5 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 Koon Seng Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2009: 12011: 12018: 12021: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Koon Seng Sdn Bhd by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove4decisions
  • LZAPolymer Patient Examination Glove3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K171171KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs…Koon Seng Sdn Bhd · 20181cites it

What has FDA decided for it lately?

  • K212613Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid…Koon Seng Sdn Bhd · 2021
  • K171171KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs…Koon Seng Sdn Bhd · 2018
  • K110960Royal Imperial Nitrile Examination Gloves Textured Powder-FreeKoon Seng Sdn Bhd · 2011
  • K093375KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50UG or Less)Koon Seng Sdn Bhd · 2009
  • K013537Royal Imperial Powdered Latex Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less)Koon Seng Sdn Bhd · 2001
  • K012714Royal Imperial Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50…Koon Seng Sdn Bhd · 2001
  • K891821Patient Examination Gloves (Latex)Koon Seng Sdn Bhd · 1989

All 7 as Koon Seng Sdn Bhd →