# K143349: Gynomunal

- Pathway: 510(k) (Traditional)
- Applicant: Polichem S.A
- Decided: Sep 16, 2015 after 296 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
- K232040: Gynatrof (2024), 0 descendants of its own

## Indications for use
Gynomunal 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 with polyisoprene condoms, but not with polyurethane condoms.

Source page: https://510kreport.com/device/K143349
Methodology: https://510kreport.com/methodology