# K150147: Lubrigyn cream

- Pathway: 510(k) (Special)
- Applicant: Uniderm Farmaceutici Srl
- Decided: Feb 19, 2015 after 28 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132772: Lubrigyn Cream, Uniderm Farmaceutici Srl (2014) Summary page 4.

## Indications for use
LUBRIGYN CREAM 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 not compatible with natural rubber latex, polyisoprene and polyurethane condoms

Source page: https://510kreport.com/device/K150147
Methodology: https://510kreport.com/methodology