Cleared Traditional

ONE Nitrile Condom

K243967 · Global Protection Corp. · Obstetrics & Gynecology
Apr 2025
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K243967 is an FDA 510(k) clearance for the ONE Nitrile Condom, a Condom, Synthetic (Class II — Special Controls, product code MOL), submitted by Global Protection Corp. (Boston, US). The FDA issued a Cleared decision on April 8, 2025, 106 days after receiving the submission on December 23, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K243967 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2024
Decision Date April 08, 2025
Days to Decision 106 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code MOL — Condom, Synthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

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