Trojan Ribbed Lubri. Latex Condoms Modified Label
510(k) K901194
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK901194 | Date16 Apr 1990 | 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- Withdrawn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, 25 Sep 2026
The Trojan Ribbed Lubricated Latex Condoms are a type of condom, classified as a Class II medical device. They are made of latex and are designed to provide a barrier against pregnancy and disease transmission.
The condoms are supplied as a single-use device and are intended for use in obstetrics and gynecology applications. They are regulated under the product code HIS and have been cleared by the FDA under the 510(k) clearance process, with the regulation number 884.5300.
Other devices from Carter Products
Questions
AI-generated answers, 25 Sep 2026
What are Trojan Ribbed Latex Condoms used for?
They are designed to provide a barrier against pregnancy and disease transmission, intended for use in obstetrics and gynecology applications.
Are Trojan Ribbed Latex Condoms single-use or reusable?
They are supplied as a single-use device.
What is the regulatory status of Trojan Ribbed Latex Condoms?
They have been cleared by the FDA under the 510(k) clearance process, with the regulation number 884.5300.