510(k) Report

FDA applicant

Gimbel Glove Co., LLC

Phoenix, AZ2 decisions1994–20000 recalls

FDA records 2 decisions for Gimbel Glove Co., LLC (Phoenix, AZ) from 1994 to 2000: 2 510(k) clearances. All are in product code KGO (Surgeon'S Gloves). No recall is linked to its devices.

FDA’s records also spell it “Gimbel Glove Co.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Gimbel Glove Co., LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gimbel Glove Co., LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gimbel Glove Co., LLC 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?

  • KGOSurgeon'S Gloves2decisions

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.

  • K003063Gimbel Puncture Resistant Latex Surgical Glove with Puncture Resistance Fingertip ProtectionGimbel Glove Co., LLC · 20001cites it

What has FDA decided for it lately?

  • K003063Gimbel Puncture Resistant Latex Surgical Glove with Puncture Resistance Fingertip ProtectionGimbel Glove Co., LLC · 2000
  • K925861Gimbel Puncture Resistant Surgical GloveGimbel Glove Co. · 1994

The one decision as Gimbel Glove Co., LLC →The one decision as Gimbel Glove Co. →