Spermicidally Lubricated Condom
by Ansell, Inc. 510(k)
Active
510(k) K940047
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940047 | Date19 Dec 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
This device is a male condom (FDA classification: HIS) designed to provide contraceptive protection by physically preventing sperm from entering the vagina. The spermicidal lubrication enhances effectiveness by adding a chemical barrier against conception, combining mechanical and chemical contraceptive methods.
The condom is supplied as a single-use, non-sterile product intended for use during sexual intercourse. It is classified as a Class II medical device under FDA regulation 884.5300 and has received FDA 510(k) clearance (K940047) as substantially equivalent to a predicate device. No specific MRI safety or sterilization requirements are noted in the data.
Other devices from Ansell, Inc.
Questions
AI-generated answers, 19 Sep 2026
What makes this condom different from standard condoms, and how does it improve contraceptive effectiveness?
This condom is uniquely designed with spermicidal lubrication, combining a mechanical barrier (the condom itself) with a chemical barrier to enhance contraceptive protection. The spermicide adds an extra layer of defense by chemically inhibiting sperm, which helps reduce the risk of conception beyond what a standard condom provides.
Is this condom intended for single-use only, and if so, why?
Yes, this condom is explicitly labeled as a single-use product. This is a standard practice for condoms to ensure hygiene, prevent cross-contamination, and maintain effectiveness, as reuse could compromise the integrity of the barrier and increase the risk of breakage or infection.
What does the non-sterile classification mean for this condom, and how should it be handled?
The non-sterile classification means it is not processed to eliminate all microorganisms, so it is not intended for use in sterile medical procedures. For safe use, it should be handled with clean, dry hands and stored in a cool, dry place away from direct sunlight or extreme temperatures to preserve its integrity and effectiveness.
How do I know which size or model of this condom is right for me, and are multiple sizes available?
While the provided data does not specify exact sizing details, the manufacturer offers multiple models (as indicated by the varied registration numbers). To determine the correct fit, refer to the packaging or manufacturer’s guidelines, which typically include sizing charts or recommendations based on measurements like circumference or length. Always choose a size that fits comfortably without excessive tightness or looseness.
What regulatory pathway was followed for this condom’s approval, and what does that mean for its safety and effectiveness?
This condom received FDA 510(k) clearance (K940047) under the Traditional pathway, meaning it was determined to be substantially equivalent to a predicate device already on the market. This process ensures it meets established safety and performance standards for Class II medical devices, specifically for contraceptive condoms, as classified under FDA regulation 884.5300. The review was conducted by the Obstetrics/Gynecology (OB) advisory committee.