Trojan Plus II Condom
510(k) K833765
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833765 | Date16 Dec 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Trojan Plus II
- 510(k) Number
- FDA Product Code
- HIS
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5300
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Trojan Plus II is a latex condom, a barrier contraceptive designed to prevent sexually transmitted infections and unintended pregnancies during vaginal intercourse. It provides physical protection by forming a barrier between partners, reducing the risk of pathogen transmission while also serving as a mechanical contraceptive method.
These condoms are supplied in single-use, non-sterile packaging and are classified as a Class II medical device under FDA regulations. They are intended for use in a variety of settings, including clinical and home environments, and are regulated under the FDA’s 510(k) clearance process (K833765). No MRI safety information or reusable variants are specified for this product.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Trojan Plus II condom, and how does it function to prevent unintended outcomes during intercourse?
The Trojan Plus II condom is designed as a barrier contraceptive to prevent both sexually transmitted infections (STIs) and unintended pregnancies during vaginal intercourse. It works by forming a physical barrier between sexual partners, blocking pathogens and sperm from passing between them. This dual function makes it a reliable method for both contraception and infection prevention.
Are the Trojan Plus II condoms sterile, and if not, what does that mean for their use?
No, the Trojan Plus II condoms are not sterile—they are supplied in non-sterile packaging. This means they are not intended for use in sterile medical procedures (e.g., surgical settings) but are safe for their intended use as a contraceptive and STI prevention barrier in clinical or home environments, where sterility is not required.
How are the Trojan Plus II condoms supplied, and are they meant for single-use only?
The Trojan Plus II condoms are supplied in single-use packaging, meaning each condom is intended for one use only. This design ensures hygiene and prevents cross-contamination between uses, aligning with best practices for barrier contraceptives.
What regulatory pathway was followed for the FDA clearance of the Trojan Plus II, and which advisory committee reviewed it?
The Trojan Plus II received FDA clearance through the 510(k) process (traditional pathway) with the decision code SESE (Substantially Equivalent). The product was reviewed by the Obstetrics/Gynecology (OB) Advisory Committee, reflecting its classification under FDA’s Class II medical device regulations for barrier contraceptives.
Are there multiple sizes or models of the Trojan Plus II condom, and how would a clinician or buyer determine the correct fit?
While the provided data lists multiple FEI numbers (e.g., 3005203207, 2084177), these are registration identifiers for lot tracking, not distinct sizes or models. The Trojan Plus II is marketed as a standard latex condom, and sizing would follow typical manufacturer guidelines (e.g., small, medium, large) based on user measurements. Buyers should refer to the manufacturer’s packaging or documentation for specific sizing recommendations.