510(k) Report

FDA applicant

Unigloves, Ltd.

Avondale, AZ3 decisions1989–19940 recalls

FDA records 3 decisions for Unigloves, Ltd. (Avondale, AZ) from 1989 to 1994: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). 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 Unigloves, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Unigloves, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Unigloves, Ltd. 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?

  • LYYLatex Patient Examination Glove2decisions
  • KGOSurgeon'S Gloves1decision

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.

  • K932550Powder Free Examination GlovesUnigloves, Ltd. · 19941cites it

What has FDA decided for it lately?

  • K932550Powder Free Examination GlovesUnigloves, Ltd. · 1994
  • K902449Sterile Surgeon's GlovesUnigloves, Ltd. · 1991
  • K890872Patient Examination GlovesUnigloves, Ltd. · 1989

All 3 as Unigloves, Ltd. →