# K180136: BioNude Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Good Clean Love, Inc.
- Decided: Jun 1, 2018 after 135 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
BioNude 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 and polyisoprene condoms. It is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K180136
Methodology: https://510kreport.com/methodology