# K171172: Skyn Original Polyisoprene Lubricated Male Condom - Flavored

- Pathway: 510(k) (Abbreviated)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Aug 2, 2017 after 103 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: 3 generations back to K941258 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160399: Skyn Original Polyisoprene Lubricated Male Condom, Ansell Healthcare Products, LLC (2016) Summary page 4.

## Most influential descendants
- K182438: Synthetic Polyisoprene Lubricated Male Condom - 5 senses (2018), 0 descendants of its own

## Indications for use
Skyn Original Polyisoprene Lubricated Male Condom - Flavored 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/K171172
Methodology: https://510kreport.com/methodology