# K220226: X-Y Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: R&R Medical Corporation, Ltd.
- Decided: Mar 28, 2023 after 425 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
Longest line of descent: 6 generations back to K810310 (1981). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142790: OneTouch Lubricant Gel, Thai Nippon Rubber Industry Co., Ltd. (2015) Summary page 4.

## Indications for use
X-Y Lubricating Jelly is a personal lubricant, for vaginal and/or penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K220226
Methodology: https://510kreport.com/methodology