# K163107: Lifestyles Zero Lubricated Latex Male Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Jan 23, 2017 after 77 days
- Product code: HIS (Condom)
- 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; 2 cite 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 4.

## Most influential descendants
- K200672: Durex Penck Standard, Durex Penck XL (2020), 3 descendants of its own
- K213647: Durex Patronus Wide (2022), 1 descendant of its own
- K252521: LifeStyles® HydraFeel Natural Rubber Latex Condom (2025), 0 descendants of its own
- K220489: Durex Patronus CloseFit, Durex Patronus Regular (2022), 0 descendants of its own
- K222068: Durex Penck III Regular (2022), 0 descendants of its own

## Indications for use
The Lifestyles Zero Lubricated Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

Source page: https://510kreport.com/device/K163107
Methodology: https://510kreport.com/methodology