# K132772: Lubrigyn Cream

- Pathway: 510(k) (Traditional)
- Applicant: Uniderm Farmaceutici Srl
- Decided: Aug 22, 2014 after 351 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: 5 generations back to K810310 (1981). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112217: ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting Vaginal Moisturizer, Polichem S.A (2012) Summary page 4.

## Most influential descendants
- K150147: Lubrigyn cream (2015), 0 descendants of its own

## 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/K132772
Methodology: https://510kreport.com/methodology