# DEN210034: ONE Male Condom

- Pathway: De Novo (Direct)
- Applicant: Global Protection Corp.
- Decided: Feb 23, 2022 after 181 days
- Product code: QRZ (External Condom For Anal Intercourse Or Vaginal Intercourse)
- Device class: 2
- Regulation: 21 CFR 884.5305
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
The ONE Male Condom is used for contraception to help reduce the risk of pregnancy during vaginal intercourse and for prophylactic purposes to help reduce the transmission of sexually transmitted infections (STIs) during vaginal or anal intercourse. The ONE Male Condom should be used with a condom compatible lubricant when used for anal intercourse.

Source page: https://510kreport.com/device/DEN210034
Methodology: https://510kreport.com/methodology