Cleared Traditional

ONE Nitrile Condom

K240896 · Global Protection Corp. · Obstetrics & Gynecology
Aug 2024
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K240896 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 August 23, 2024, 144 days after receiving the submission on April 1, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K240896 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2024
Decision Date August 23, 2024
Days to Decision 144 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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