# K955672: Trojan Polyurethane Condom (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Carter Products
- Decided: Aug 29, 1996 after 302 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.
No later device cites it as a predicate yet.
0 of 1 device 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® Latex Condoms: named in the summary without a submission number

## Indications for use
The subject polyurethane condom has the same intended use as the predicate latex condoms. The condom 1s used for contraceptive and for prophylactic purposes (helping to prevent transmission of venereal disease). If used properly, condoms will help to reduce the risk of transmission of HIV intection (AIDS) and many other sexually transmitled discases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. No contraceptive can guarantee 100% effectiveness. Any use of thc condom for other than vaginal intercourse can incrcase the potential of damage to the condom. For maximurmn benefits, it is important to follow the instructions for use that accompany the product. Failure to do so may result in the loss of the benefits of a condom. During intimate contact, lesions and various body fluids can transmit sexually transmitted diseases (STDs); therefore, a new condom should be applied each and every time before any such contact occurs, The condom with spermicidal lubricant combines the use of a condom with a spermicidal lubricant. The spermicide, nonoxynol-9, reduces the number of active sperm. thereby decreasing the risk of pregnancy if erection is lost before withdrawal and some semen spills outside the condom. However, the extent of decreased risk has not been established. A condom with spermicidal lubricant should not be used as a substitute for the combined use of a vaginal spermicide and a condom.

Source page: https://510kreport.com/device/K955672
Methodology: https://510kreport.com/methodology