# K941258: Latex Condom

- Pathway: 510(k) (Traditional)
- Applicant: Suretex, Ltd.
- Decided: Dec 6, 1995 after 630 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
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K163107: Lifestyles Zero Lubricated Latex Male Condom (2017), 5 descendants of its own
- K070800: Lifestyles Lubricated Polyisoprene Latex Male Condom (2008), 5 descendants of its own
- K160399: Skyn Original Polyisoprene Lubricated Male Condom (2016), 4 descendants of its own
- K200672: Durex Penck Standard, Durex Penck XL (2020), 3 descendants of its own
- K213647: Durex Patronus Wide (2022), 1 descendant of its own

## Recalls of this device
- Nov 5, 2012 · Class II · Z-0717-2013: One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.

Source page: https://510kreport.com/device/K941258
Methodology: https://510kreport.com/methodology