K240896 is an FDA 510(k) clearance for the ONE Nitrile Condom. Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.
Submitted by Global Protection Corp. (Boston, US). The FDA issued a Cleared decision on August 23, 2024 after a review of 144 days - within the typical 510(k) review window.
This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.
View all Global Protection Corp. devices
NCT05912283
Completed
Interventional
Industry-sponsored
Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom
A Functional Performance and Acceptability Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom
| Condition studied |
Sexually Transmitted Diseases |
| Study design |
Crossover |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Mags Beksinska, PhD |
| Sponsor |
Karex Industries Sdn. Bhd.
(industry)
|
Started 2023-06-02
→
Primary completion 2024-01-31
Primary outcome
Clinical breakage
Secondary outcome
Genital discomfort
Study completed - no results published.
This trial concluded in 2024 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov