# K040428: Multiple Erozone Bodyglide Fluid, Erozone Bodyglide Gel, Erozone Latex Dressing, Erozone Bodyglide Natural Foam

- Pathway: 510(k) (Traditional)
- Applicant: R & K International Cosmetics
- Decided: Aug 9, 2005 after 537 days
- Product code: NUC (Lubricant, Personal)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K133233: Pjur Original, Pjur Woman, Pjur Man Extreme Glide (2014), 2 descendants of its own
- K150153: Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant (2015), 1 descendant of its own
- K213892: Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine (2023), 0 descendants of its own
- K133336: Pjur (R) Siliconegel, Pjur (R) Basic Personal Glide, Pjur (R) Light, Pjur (R) Med Premium Glide (2014), 0 descendants of its own

## Indications for use
"Erozone" personal lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnotic or therapeutic device. "Erozone" is recommended as a personal lubricant to enhance intiate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. "Erozone" Personal Lubricants may be used with condoms.

Source page: https://510kreport.com/device/K040428
Methodology: https://510kreport.com/methodology