# K050828: Trojan Supra Lubricated Polyurethane Male Condom

- Pathway: 510(k) (Traditional)
- Applicant: Church & Dwight Co., Inc.
- Decided: Feb 28, 2006 after 333 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: 1 generation back to K942697 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942697: Trojan Polyurethane Condom, Carter Products (1995) Summary page 1.

## Most influential descendants
- K080752: Conceivex Latex-Free Semen Collector (2008), 0 descendants of its own

## Indications for use
The TROJAN SUPRA® Lubricate Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).

Source page: https://510kreport.com/device/K050828
Methodology: https://510kreport.com/methodology