Cleared Traditional

K120286 - TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT

K120286 is an FDA 510(k) clearance for TROJAN HER PLEASURE (RIBBED) ECSTASY LA..., manufactured by Church & Dwight Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K120286 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
140d
Days
Class 2
Risk

K120286 is an FDA 510(k) clearance for the TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on June 19, 2012 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Church & Dwight Co., Inc. devices

FDA 510(k) Submission Details - K120286

510(k) Number K120286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2012
Decision Date June 19, 2012
Days to Decision 140 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 160d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIS Condom

All 186
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K120286.
MALE LATEX CONDOM
K121241 · Nulatex Sdn. Bhd. · Feb 2013
LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
K120555 · Medical-Latex (Dua) Sdn. Bhd · Nov 2012
ORANGE COLORED CONDOMS ORANGE SCENT
K113056 · Karex Industries Sdn. Bhd. · Jul 2012
TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
K120287 · Church & Dwight Co., Inc. · May 2012
TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
K120249 · Church & Dwight Virginia Co., Inc. · May 2012
LIFESTYLES ZERO LUBRICATED LATEX CONDOM
K120394 · Ansell Heathcare Products, LLC · May 2012