# K221243: OFNat Lubricant (L15)

- Pathway: 510(k) (Traditional)
- Applicant: Suretex Limited
- Decided: Sep 30, 2022 after 151 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122054: Lifestyles Natural Personal Lubricant, Ansell Healthcare Products, LLC (2013) Summary page 4.

## Indications for use
OFNat Lubricant (L15) is a personal lubricant for vaginal and penile 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 polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K221243
Methodology: https://510kreport.com/methodology