510(k) Report

FDA applicant

Shanghai Giantmax Plastic Product Corp.

Great Neck, NY2 decisions2003–20030 recalls

FDA records 2 decisions for Shanghai Giantmax Plastic Product Corp. (Great Neck, NY) in 2003: 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 Shanghai Giantmax Plastic Product Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Giantmax Plastic Product Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Giantmax Plastic Product Corp. 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 Glove2decisions

What has FDA decided for it lately?

  • K032745Shanghai Giantmax Powdered Clear Vinyl Examination GlovesShanghai Giantmax Plastic Product Corp. · 2003
  • K032746Shanghai Giantmax Clear Vinyl Powder Free Examination GlovesShanghai Giantmax Plastic Product Corp. · 2003

All 2 as Shanghai Giantmax Plastic Product Corp. →