# K182438: Synthetic Polyisoprene Lubricated Male Condom - 5 senses

- Pathway: 510(k) (Abbreviated)
- Applicant: Sxwell USA, LLC
- Decided: Dec 6, 2018 after 90 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: 4 generations back to K941258 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171172: Skyn Original Polyisoprene Lubricated Male Condom - Flavored, Ansell Healthcare Products, LLC (2017) Summary page 4.

## Indications for use
Synthetic Polyisoprene Lubricated Male Condom - 5 Senses 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/K182438
Methodology: https://510kreport.com/methodology