# K141034: Azul Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Church & Dwight Co., Inc.
- Decided: Jul 21, 2014 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: 5 generations back to K810310 (1981). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 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 1.
- K124044: Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants, Seven Oaks Ranch, Inc. (2013) Summary page 1.

## Most influential descendants
- K180764: TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) (2018), 1 descendant of its own
- K253989: HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) (2026), 0 descendants of its own
- K202667: Personal Lubricant Jelly (2021), 0 descendants of its own

## Indications for use
Azul Personal Lubricant is a 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K141034
Methodology: https://510kreport.com/methodology