510(k) Report

FDA applicant

Gigantic International Corp.

Whittier, CA3 decisions1989–19890 recalls

FDA records 3 decisions for Gigantic International Corp. (Whittier, CA) in 1989: 3 510(k) clearances. Most are in product codes LYZ (Vinyl 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 Gigantic International Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gigantic International Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gigantic International 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 Glove1decision
  • KGOSurgeon'S Gloves1decision
  • LYYLatex Patient Examination Glove1decision

What has FDA decided for it lately?

  • K894928Sterile Latex Surgeon's GlovesGigantic International Corp. · 1989
  • K892766Patient Examination Gloves (Vinyl)Gigantic International Corp. · 1989
  • K892923Latex Patient Examination GlovesGigantic International Corp. · 1989

All 3 as Gigantic International Corp. →