Cleared Special

TROJAN EXTRA LARGE LATEX CONDOM

K001212 · Armkel, LLC · Obstetrics & Gynecology
May 2000
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K001212 is an FDA 510(k) clearance for the TROJAN EXTRA LARGE LATEX CONDOM, a Condom (Class II — Special Controls, product code HIS), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on May 9, 2000, 25 days after receiving the submission on April 14, 2000. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K001212 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2000
Decision Date May 09, 2000
Days to Decision 25 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

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

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