Cleared Traditional

K180104 - Trojan Chain Reaction Natural Rubber La...

K180104 is the FDA 510(k) clearance for Trojan Chain Reaction Natural Rubber La... by Church & Dwight Co., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K180104 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
57d
Days
Class 2
Risk

K180104 is an FDA 510(k) clearance for the Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant. 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 March 14, 2018 after a review of 57 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

Submission Details

510(k) Number K180104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2018
Decision Date March 14, 2018
Days to Decision 57 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
103d faster than avg
Panel avg: 160d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K180104.
CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))
K201067 · Cupid Limited · Aug 2020
Extremely Thin 003, ZERO ZERO THREE
K192669 · Okamoto USA, Inc. · Jul 2020
One Touch
K181844 · Thai Nippon Rubber Industry Public Company, Ltd. · Apr 2019
One Touch Condom with Benzocaine
K171213 · Thai Nippon Rubber Industry Public Company Limited. · Jan 2018
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC · May 2000