Cleared Abbreviated

LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9

K024324 · Global Protection Corp. · Obstetrics & Gynecology
Mar 2003
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K024324 is an FDA 510(k) clearance for the LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9, a Condom (Class II — Special Controls, product code HIS), submitted by Global Protection Corp. (Boston, US). The FDA issued a Cleared decision on March 25, 2003, 89 days after receiving the submission on December 26, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K024324 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2002
Decision Date March 25, 2003
Days to Decision 89 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HIS — Condom
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

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