# K161585: Mano and Mano Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Mano and Mano Proprietary Limited
- Decided: Sep 6, 2016 after 90 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: 4 generations back to K810310 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120650: Poise Personal Lubricant, Kimberly-Clark Corporation (2012) Summary page 4.

## Indications for use
Mano and Mano Personal Lubricant is a water‐based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, 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/K161585
Methodology: https://510kreport.com/methodology