# K120394: Lifestyles Zero Lubricated Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Ansell Heathcare Products, LLC
- Decided: May 8, 2012 after 90 days
- Product code: HIS (Condom)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K952415 (1996). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103119: Billy Boy Male Latex Condom, Sheila Pickering PHD (2011) Summary page 1.

## Most influential descendants
- K153016: aoni Natural Rubber Latex Condom (2016), 0 descendants of its own

## Recalls of this device
- Jan 14, 2013 · Class II · Z-0838-2013: Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and

## Indications for use
The LifeStyles® Zero® condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Source page: https://510kreport.com/device/K120394
Methodology: https://510kreport.com/methodology