Cleared Traditional

TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR

K904000 · Armkel, LLC · Obstetrics & Gynecology
Feb 1991
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K904000 is an FDA 510(k) clearance for the TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR, a Condom (Class II — Special Controls, product code HIS), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 19, 1991, 174 days after receiving the submission on August 29, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K904000 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1990
Decision Date February 19, 1991
Days to Decision 174 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

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

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