510(k) Report

FDA applicant

Worlds-Best Gummivarefabrik A/S

Viby J., DK1 decision1998–19980 recalls

FDA records 1 decision for Worlds-Best Gummivarefabrik A/S (Viby J., DK) in 1998: 1 510(k) clearance. All are in product code HIS (Condom). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Worlds-Best Gummivarefabrik A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Worlds-Best Gummivarefabrik A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Worlds-Best Gummivarefabrik A/S 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?

  • HISCondom1decision

What has FDA decided for it lately?

  • K971028Worlds Best Brand Non-Lubricated, Worlds Best Brand LubricatedWorlds-Best Gummivarefabrik A/S · 1998

The one decision as Worlds-Best Gummivarefabrik A/S →