Hardcover Male Latex Condoms (With Spermicide)
510(k) K991047
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991047 | Date18 Jun 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Hardcover Condoms Male Latex Condoms, (with Spermicide)
- 510(k) Number
- FDA Product Code
- LTZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5310
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Condom With Nonoxynol-9, classified under product code LTZ. It consists of male latex condoms treated with spermicide to provide contraceptive protection and reduce the risk of sexually transmitted infections, including HIV. The design adheres to regulatory standards for barrier contraception and includes nonoxynol-9 as an additional protective agent.
Hardcover Male Latex Condoms (With Spermicide) are single-use, non-sterile barrier devices intended for vaginal use during sexual intercourse. They are supplied in various sizes and packaging configurations, as indicated by the registration numbers (e.g., 3003592318, 3013770781). The device received FDA 510(k) clearance under an abbreviated review process, classified as Class II with special controls. Storage conditions and additional regulatory details are governed by FDA regulation number 884.5310.
Other devices from Hardcover Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of Hardcover Male Latex Condoms (With Spermicide)?
These condoms are designed as a barrier contraceptive to prevent pregnancy and reduce the risk of sexually transmitted infections (STIs), including HIV. The spermicide (nonoxynol-9) provides an additional protective layer, enhancing their effectiveness as both a contraceptive and STI prevention method during vaginal intercourse.
Are Hardcover Male Latex Condoms (With Spermicide) sterile or single-use?
These condoms are single-use only and are non-sterile. They are intended for one-time use during sexual intercourse and should not be reused, as this could compromise their protective integrity and increase the risk of failure or infection.
What sizes or packaging configurations are available for Hardcover Male Latex Condoms (With Spermicide)?
The device is supplied in multiple sizes and packaging configurations, each identified by unique registration numbers such as 3003592318, 3013770781, 3008808138, and others. These variations likely cater to different user preferences for fit and comfort. Always verify the specific size or packaging against the product labeling or packaging details.
How should Hardcover Male Latex Condoms (With Spermicide) be stored?
While the description does not specify exact storage conditions beyond regulatory compliance, latex condoms generally require protection from extreme temperatures, direct sunlight, and moisture. They should be stored in a cool, dry place, away from sharp objects or sources of heat. Check the packaging for any manufacturer-specific storage instructions.
What regulatory pathway was followed for FDA clearance of these condoms?
Hardcover Male Latex Condoms (With Spermicide) received FDA 510(k) clearance under an abbreviated review process, classified as Class II with special controls. The submission was reviewed by the Obstetrics/Gynecology (OB) Advisory Committee and determined to be substantially equivalent to a legally marketed predicate device. The clearance number is K991047, and the device falls under product code LTZ.