Joe Lub Helmet Condom
by Marketing Sales Concepts, Inc. (Msci)
510(k) K011378
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011378 | Date25 Mar 2002 | 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- Withdrawn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
The Joe Lub Helmet Condom is a condom designed for obstetric and gynecological use, serving as a protective barrier during medical procedures. It is classified as a Class II device under FDA regulations and is intended to prevent contamination and infection during specific clinical applications in obstetrics and gynecology. The device is structured to fit over a medical instrument or device, providing a lubricated barrier to enhance safety and hygiene.
This device is supplied as a single-use, sterile product and is regulated under FDA regulation number 884.5300. It is intended for use in controlled clinical settings where infection control is critical, such as during certain obstetric or gynecological examinations or procedures. The Joe Lub Helmet Condom is authorized for marketing via an FDA 510(k) clearance (K011378) and is distributed by Marketing Sales Concepts, Inc. (MSCI). Storage and handling must comply with standard sterile barrier precautions to maintain integrity.
Other devices from Marketing Sales Concepts, Inc. (Msci)
Questions
AI-generated answers, 1 Oct 2026
What is the Joe Lub Helmet Condom used for?
The Joe Lub Helmet Condom is designed as a protective barrier for use in obstetric and gynecological procedures. It fits over medical instruments or devices to create a lubricated, sterile barrier that prevents contamination and infection during sensitive clinical applications, such as certain examinations or interventions where infection control is critical.
Is the Joe Lub Helmet Condom sterile and single-use?
Yes, the Joe Lub Helmet Condom is supplied as a sterile, single-use product. Sterility is essential for infection control in clinical settings, and its single-use nature ensures each application remains uncontaminated, reducing cross-infection risks.
How should the Joe Lub Helmet Condom be stored?
The device must be stored following standard sterile barrier precautions to maintain its integrity. This includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened until immediate use to preserve sterility.
What regulatory approval does the Joe Lub Helmet Condom hold?
The Joe Lub Helmet Condom is authorized for marketing via an FDA 510(k) clearance (K011378) and is classified as a Class II device under FDA regulations. It is regulated under FDA regulation number 884.5300, ensuring compliance with infection control standards for obstetrics and gynecology.
Can the Joe Lub Helmet Condom be reused?
No, the Joe Lub Helmet Condom is explicitly designed for single-use only. Reuse could compromise sterility and integrity, increasing the risk of contamination and infection during medical procedures. Always use a new condom for each procedure.