# K160399: Skyn Original Polyisoprene Lubricated Male Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Jul 25, 2016 after 164 days
- Product code: MOL (Condom, Synthetic)
- 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: 2 generations back to K941258 (1995). 2 ancestors in all.
4 later devices descend from it; 3 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)
- K070800: Lifestyles Lubricated Polyisoprene Latex Male Condom, Ansell Healthcare Products, LLC (2008) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Jun 23, 2022 · Class II · Z-1530-2022: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

## Indications for use
The Skyn Original Polyisoprene Lubricated Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STI's).

Source page: https://510kreport.com/device/K160399
Methodology: https://510kreport.com/methodology