510(k) Report

FDA applicant

Honyee Enterprise Co.

Tainan, TW2 decisions1989–19900 recalls

FDA records 2 decisions for Honyee Enterprise Co. (Tainan, TW) from 1989 to 1990: 2 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and LYY (Latex Patient Examination Glove). 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 Honyee Enterprise Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Honyee Enterprise Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Honyee Enterprise Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYZVinyl Patient Examination Glove1decision
  • LYYLatex Patient Examination Glove1decision

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.

  • K893822Honyee Vinyl Examination GlovesHonyee Enterprise Co. · 19891cites it

What has FDA decided for it lately?

  • K896957Powder-Free Vinyl Patient Examination GlovesHonyee Enterprise Co. · 1990
  • K893822Honyee Vinyl Examination GlovesHonyee Enterprise Co. · 1989

All 2 as Honyee Enterprise Co. →