# K234099: Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Select Labs, LLC
- Decided: Jun 7, 2024 after 164 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 K890863 (1989). 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)
- K191480: Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid), Trigg Laboratories, Inc. D/B/A Wet International (2019) Summary page 5.
- K212260: Sensuva Premium Silicone Personal Lubricant, Valencia Naturals, Inc. (2022) Summary page 5.

## Indications for use
Select Hybrid Personal Lubricant 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, polyurethane, and polyisoprene condoms. Select Pure Silicone Personal Lubricant 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, polyurethane, and polyisoprene condoms.

Source page: https://510kreport.com/device/K234099
Methodology: https://510kreport.com/methodology
