# K240379: TROJAN SIS Synthetic Latex Condom with Silicone Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Church & Dwight Co., Inc.
- Decided: Oct 8, 2024 after 244 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: 2 generations back to K100767 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171639: Trojan Supra Lubricated Polyurethane Male Condom, Church & Dwight Co., Inc. (2017) Summary page 5.

## Indications for use
The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K240379
Methodology: https://510kreport.com/methodology