# K100767: Trojan Supra Lubricated Polyurethane Male Condom

- Pathway: 510(k) (Traditional)
- Applicant: Church & Dwight Co., Inc.
- Decided: Apr 5, 2011 after 383 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
No predicates in its family tree.
4 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) TROJAN-ENZ® Brand Lubricated Latex Male Condom (Pre-1976): named in the summary without a submission number

## Most influential descendants
- K203541: Okamoto 002 Lubricated Polyurethane Male Condom (2022), 1 descendant of its own
- K171639: Trojan Supra Lubricated Polyurethane Male Condom (2017), 1 descendant of its own
- K252158: Sagami Original 002 Polyurethane Male Condom (2026), 0 descendants of its own
- K240379: TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (2024), 0 descendants of its own

## Indications for use
The TROJAN SUPRA® Lubricated Polyurethane Male 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/K100767
Methodology: https://510kreport.com/methodology