510(k) Report

FDA applicant

Shanghai China Star Corp

Great Neck, NY5 decisions1999–20070 recalls

FDA records 5 decisions for Shanghai China Star Corp (Great Neck, NY) from 1999 to 2007: 5 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYZ (Vinyl Patient Examination Glove). Its devices cite 4 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 Shanghai China Star Corp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai China Star Corp by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai China Star Corp’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?

  • LZAPolymer Patient Examination Glove3decisions
  • LYZVinyl Patient Examination Glove2decisions

Whose devices does it build on?

Its devices cite 4 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.

  • K071072Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination GloveShanghai China Star Corp · 20071cites it

What has FDA decided for it lately?

  • K071072Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination GloveShanghai China Star Corp · 2007
  • K010247Shanghai Chinastar Power-Free Blue Nitril Examination GlovesShanghai China Star Corp · 2001
  • K003675Shanghai China Star Corp Powdered Blue Nitrile Patient Examination GlovesShanghai China Star Corp · 2001
  • K992206Powder-Free Vinyl Patient Examination GlovesShanghai China Star Corp · 1999
  • K992205Pre-Powdered Vinyl Patient Examination GlovesShanghai China Star Corp · 1999

All 5 as Shanghai China Star Corp →