# K221829: Wet Flavored Personal Lubricants

- Pathway: 510(k) (Traditional)
- Applicant: Trigg Laboratories, Inc.
- Decided: Sep 23, 2022 after 92 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: 7 generations back to K810310 (1981). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172447: JO Gelato Flavored Personal Lubricants, United Consortium (2017) Summary page 4.

## Indications for use
Wet Flavored Personal Lubricants are personal lubricants 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. The product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K221829
Methodology: https://510kreport.com/methodology