Cleared Traditional

K100767 - TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
(FDA 510(k) Clearance)

K100767 · Church & Dwight Co., Inc. · Obstetrics & Gynecology
Apr 2011
Decision
383d
Days
Class 2
Risk

K100767 is an FDA 510(k) clearance for the TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM, a Condom, Synthetic (Class II — Special Controls, product code MOL), submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on April 5, 2011, 383 days after receiving the submission on March 18, 2010. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K100767 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2010
Decision Date April 05, 2011
Days to Decision 383 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

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