# K231908: 45 Micron Polyisoprene Condom

- Pathway: 510(k) (Traditional)
- Applicant: Suretex Limited
- Decided: Oct 27, 2023 after 120 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The 45 Micron Polyisoprene 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/K231908
Methodology: https://510kreport.com/methodology