# K050913: Dick's Formalwear Male Latex Condom

- Pathway: 510(k) (Traditional)
- Applicant: Dick'S Formalwear, Inc.
- Decided: Apr 4, 2006 after 357 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. The FDA summary names no predicate by number.

## Indications for use
Dick's Formalwear® Male Latex Condoms is to be used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases, including human immunodeficiency virus (HIV)).

Source page: https://510kreport.com/device/K050913
Methodology: https://510kreport.com/methodology