510(k) Report

FDA applicant

Ug Healthcare (Usa), Inc.

Costa Mesa, CA3 decisions2006–20120 recalls

FDA records 3 decisions for Ug Healthcare (Usa), Inc. (Costa Mesa, CA) from 2006 to 2012: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Its devices cite 2 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 Ug Healthcare (Usa), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ug Healthcare (Usa), Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ug Healthcare (Usa), Inc.’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 Glove2decisions
  • LZAPolymer Patient Examination Glove1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K112012Non-Sterile, Powder-Free Blue, Nitrile Examination GlovesUg Healthcare (Usa), Inc. · 20122cite it

What has FDA decided for it lately?

  • K112012Non-Sterile, Powder-Free Blue, Nitrile Examination GlovesUg Healthcare (Usa), Inc. · 2012
  • K112005Non-Sterile, Powder-Free, Green Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms…Ug Healthcare (Usa), Inc. · 2012
  • K062688Powder-Free Black Latex Examination Glove with Protein Labeling ClaimUg Healthcare (Usa), Inc. · 2006

All 3 as Ug Healthcare (Usa), Inc. →