# K180828: Natureplex Warm Touch Warming Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Natureplex, LLC
- Decided: Dec 20, 2018 after 265 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: 2 generations back to K955648 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052162: Sheffield Brand Warming Lubrigel Personal Lubricant, Sheffield Laboratories, Div. of Faria Limited, LLC (2006) Summary page 4.

## Indications for use
Natureplex Warm Touch Warming Jelly is a personal lubricant, for penile and/or vaginal 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms

Source page: https://510kreport.com/device/K180828
Methodology: https://510kreport.com/methodology