Remed Male Extra Strength Condom Preventor, Lucky Boy, Summit
by Remed Pharma
510(k) K993396
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993396 | Date15 Feb 2000 | 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- Withdrawn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, 27 Sep 2026
The Remed Male Extra Strength Condom Preventor, Lucky Boy, Summit is a natural rubber latex sheath designed to cover the penis. It is parallel-sided, plain-surfaced, and extra strong with no color additives.
The device is intended for over-the-counter use for contraception and prevention of sexually transmitted diseases. It functions as a physical barrier and complies with 21 CFR 801.435 regarding expiration.
Other devices from Remed Pharma
Questions
AI-generated answers, 27 Sep 2026
What is the Remed Male Extra Strength Condom Preventor?
It is a natural rubber latex sheath that covers the penis. It is designed to be extra strong, plain-surfaced, and parallel-sided without color additives.
What is this device used for?
The device is intended for over-the-counter use to prevent pregnancy and reduce the risk of sexually transmitted diseases by acting as a physical barrier.
How is the device supplied?
The device is supplied as a single-use latex condom. It is intended for personal use and must be used according to the instructions provided.
What are the specifications of the device?
The device is a parallel-sided, plain-surfaced latex sheath. It is extra strong and contains no color additives. It complies with 21 CFR 801.435 regarding expiration.
What is the regulatory status of this device?
The device has a 510(k) clearance from the FDA. The submission was reviewed by the Obstetrics/Gynecology advisory committee and was found to be substantially equivalent.