Cleared Traditional

K240379 - TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence.

K240379 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Oct 2024
Decision
244d
Days
Class 2
Risk

K240379 is an FDA 510(k) clearance for the TROJAN SIS Synthetic Latex Condom with Silicone Lubricant. Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.

Submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on October 8, 2024 after a review of 244 days - an extended review 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: 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

Submission Details

510(k) Number K240379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2024
Decision Date October 08, 2024
Days to Decision 244 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
84d slower than avg
Panel avg: 160d · This submission: 244d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOL Condom, Synthetic
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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Full Circle Regulatory Consulting, LLC
Dawn Reilly-O'Dell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05370196 Completed Interventional Industry-sponsored

Synthetic Male Condom Slippage-Breakage Study

Evaluation of the Functional Performance and Acceptability of a Synthetic Male Condom as Compared to a Commercial Latex Condom (Trojan-Enz)

600
Patients (actual)
2
Sites
Prevention
Purpose
Triple
Masking
Condition studied Contraceptive; Sexually Transmitted Diseases
Study design Crossover
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Terri Walsh, MPH
Sponsor Church & Dwight Company, Inc. (industry)
Started 2022-06-10 → Primary completion 2023-01-13 → Completed 2023-05-12
Primary outcome
Total Clinical Failure Rate
Secondary outcome
Clinical Breakage Rate
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov