510(k) Report

FDA applicant

Tg Medical (China) Incorporation

Zhangjiagang, Jiangsu Province, CN2 decisions2006–20060 recalls

FDA records 2 decisions for Tg Medical (China) Incorporation (Zhangjiagang, Jiangsu Province, CN) in 2006: 2 510(k) clearances. All are in product code LYZ (Vinyl 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 Tg Medical (China) Incorporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tg Medical (China) Incorporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tg Medical (China) Incorporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tg Medical (China) Incorporation’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?

  • LYZVinyl Patient Examination Glove2decisions

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.

  • K052985Powder Free Vinyl Examination GloveTg Medical (China) Incorporation · 20061cites it

What has FDA decided for it lately?

  • K052985Powder Free Vinyl Examination GloveTg Medical (China) Incorporation · 2006
  • K052984Powdered Vinyl Examination GloveTg Medical (China) Incorporation · 2006

All 2 as Tg Medical (China) Incorporation →