510(k) Report

FDA applicant

R & K International Cosmetics

Washington, DC1 decision2005–20050 recalls

FDA records 1 decision for R & K International Cosmetics (Washington, DC) in 2005: 1 510(k) clearance. All are in product code NUC (Lubricant, Personal). 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 R & K International Cosmetics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for R & K International Cosmetics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R & K International Cosmetics 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?

  • NUCLubricant, Personal1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K040428Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone Latex Dressing, Erozone Bodyglide Natural…R & K International Cosmetics · 20052cite it

What has FDA decided for it lately?

  • K040428Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone Latex Dressing, Erozone Bodyglide Natural…R & K International Cosmetics · 2005

The one decision as R & K International Cosmetics →