# K070800: Lifestyles Lubricated Polyisoprene Latex Male Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Mar 6, 2008 after 349 days
- Product code: MOL (Condom, Synthetic)
- 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: 1 generation back to K941258 (1995). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941258: Latex Condom, Suretex, Ltd. (1995) Summary page 1.

## Most influential descendants
- K160399: Skyn Original Polyisoprene Lubricated Male Condom (2016), 4 descendants of its own
- K171172: Skyn Original Polyisoprene Lubricated Male Condom - Flavored (2017), 1 descendant of its own
- K232470: Polyisoprene Extra Large Condom (2024), 0 descendants of its own
- K231908: 45 Micron Polyisoprene Condom (2023), 0 descendants of its own
- K182438: Synthetic Polyisoprene Lubricated Male Condom - 5 senses (2018), 0 descendants of its own

## Indications for use
The LifeStyles Lubricated Polyisoprene Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).

Source page: https://510kreport.com/device/K070800
Methodology: https://510kreport.com/methodology