Condom (Prophylactic)
by Pactec, Inc.
510(k) K874135
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874135 | Date19 Jan 1988 | 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- Withdrawn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
- 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, 1 Oct 2026
A prophylactic condom is a barrier contraceptive device designed to prevent pregnancy and reduce the risk of sexually transmitted infections during sexual intercourse. It is a latex or synthetic sheath worn over the penis to collect semen during ejaculation, thereby blocking sperm from entering the vagina or reproductive tract. Condoms are classified as Class II medical devices under FDA regulations, requiring premarket notification (510(k)) for clearance.
Condoms are supplied as single-use, sterile products in various sizes and materials, including latex and synthetic alternatives for those with latex allergies. They are intended for use in sexual health settings and are regulated under FDA regulation number 884.5300. The device is cleared for contraceptive and prophylactic purposes, with no indication of MRI compatibility or reusable applications. Storage follows standard medical device guidelines to maintain sterility and integrity until use.
Questions
AI-generated answers, 1 Oct 2026
What is a prophylactic condom used for?
A prophylactic condom is a barrier contraceptive device designed to prevent pregnancy by blocking sperm from entering the vagina or reproductive tract during sexual intercourse. It also reduces the risk of sexually transmitted infections (STIs) by creating a physical barrier between partners. This device is classified as a Class II medical device under FDA regulations and is cleared for contraceptive and prophylactic purposes.
Are Pactec prophylactic condoms single-use or reusable?
Pactec prophylactic condoms are intended for single-use only. This ensures sterility and prevents cross-contamination between uses, maintaining the device’s effectiveness in preventing pregnancy and STIs. Reuse is not recommended as it compromises the integrity and safety of the condom.
What materials are available for Pactec prophylactic condoms?
Pactec prophylactic condoms are available in latex and synthetic alternatives. The synthetic options are designed for individuals with latex allergies, providing a safe and effective alternative without compromising the device’s protective properties.
How should Pactec prophylactic condoms be stored?
Pactec prophylactic condoms should be stored according to standard medical device guidelines to maintain sterility and integrity until use. This typically involves keeping them in a cool, dry place, away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened and undamaged until ready for use.
Are there different sizes or models available for Pactec prophylactic condoms?
Yes, Pactec prophylactic condoms come in various sizes to accommodate different penis circumferences. The exact sizing options are listed in the product specifications, and selecting the appropriate size ensures proper fit, effectiveness, and comfort during use.