Not Cleared Direct

DEN210034 - ONE Male Condom (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210034 · Global Protection Corp. · Obstetrics & Gynecology device
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Feb 2022
Decision
181d
Days
Class 2
Risk

DEN210034 is an FDA 510(k) submission (not cleared) for the ONE Male Condom. Classified as External Condom For Anal Intercourse Or Vaginal Intercourse (product code QRZ), Class II - Special Controls.

Submitted by Global Protection Corp. (Boston, US). The FDA issued a Not Cleared (DENG) decision on February 23, 2022 after a review of 181 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5305 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Obstetrics & Gynecology review framework.

View all Global Protection Corp. devices

Submission Details

510(k) Number DEN210034 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 26, 2021
Decision Date February 23, 2022
Days to Decision 181 days
Submission Type Direct
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 160d · This submission: 181d
Pathway characteristics

Device Classification

Product Code QRZ External Condom For Anal Intercourse Or Vaginal Intercourse
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5305
Definition An External Condom For Anal Intercourse Or Vaginal Intercourse Is A Barrier Device Which Covers The Penis And Is Used To Prevent The Transmission Of Sexually Transmitted Infections (when Used For Anal Intercourse Or Vaginal Intercourse) And For Contraception (when Used For Vaginal Intercourse). This Classification Does Not Include Condoms Intended For Vaginal Intercourse Only.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.