# K200730: pjur WOMAN Nude pjur med SENSITIVE glide

- Pathway: 510(k) (Traditional)
- Applicant: Pjur Group Luxembourg S.A.
- Decided: Dec 17, 2020 after 272 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: 2 generations back to K183302 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201186: KY Grosz Jelly, Rb Health (Us), LLC (2020). Cleared while this submission was under review Summary page 4.

## Indications for use
pjur® med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms. pjur® WOMAN Nude for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

Source page: https://510kreport.com/device/K200730
Methodology: https://510kreport.com/methodology