Cleared Traditional

K161545 - Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant

K161545 is an FDA 510(k) clearance for Trojan XOXO Thin Male Natural Rubber 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 84-day FDA review.

K161545 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
84d
Days
Class 2
Risk

K161545 is an FDA 510(k) clearance for the Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubr.... Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on August 26, 2016 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Church & Dwight Co., Inc. devices

FDA 510(k) Submission Details - K161545

510(k) Number K161545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2016
Decision Date August 26, 2016
Days to Decision 84 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
76d faster than avg
Panel avg: 160d · This submission: 84d
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 185
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K161545.
LELO RESPECT HEX Natural Rubber Latex Condom
K162511 · Lelo, Inc. · Jan 2017
aoni Natural Rubber Latex Condom
K153016 · Guangzhou Daming United Rubber Products , Ltd. · Oct 2016
Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
K161915 · Church & Dwight Co., Inc. · Sep 2016
Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
K161195 · M3 Global Enterprises, LLC · Aug 2016
Lelo Hex Natural Rubber Latex Condom
K160644 · Lelo, Inc. · Jun 2016
O-RING Condom
K150828 · O-Ring Products, LLC · Dec 2015