# K024324: Latex Condom and Latex Condom Lubricated with Nonoxynol-9

- Pathway: 510(k) (Abbreviated)
- Applicant: Global Protection Corp.
- Decided: Mar 25, 2003 after 89 days
- Product code: HIS (Condom)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The (no particular brand name) condom, is intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, it can reduce the risk of pregnancy.

Source page: https://510kreport.com/device/K024324
Methodology: https://510kreport.com/methodology