De Novo · Granted
GrantedONE Male Condom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Protection Corp. · QRZ External Condom For Anal Intercourse Or Vaginal Intercourse
Granted on Feb 23, 2022 as a new device type through De Novo after a 181-day review.
- Decided
- Feb 23, 2022
- Review
- 181 days
- Class
- Class II
- Product code
- QRZ
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QRZ devicesQRZ External Condom For Anal Intercourse Or Vaginal Intercourse: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QRZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QRZ
Too few QRZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QRZ
No recall names QRZ since 2007.
Adverse event reports per year · QRZ
No MAUDE report names QRZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210034 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210034: ONE Male Condom.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210034
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026