Ultra Shape Condoms
510(k) K833365
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833365 | Date22 Aug 1984 | 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- Withdrawn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, 19 Sep 2026
The Ultra Shape Condoms are a type of barrier contraceptive device designed to prevent pregnancy and sexually transmitted infections. These condoms are made from latex and are intended for use during vaginal intercourse to provide a physical barrier between partners.
These condoms are supplied as single-use items and are classified under FDA regulation number 884.5300. They are intended for use in obstetrics and gynecology settings and have received FDA 510(k) clearance under the classification of HIS (Human Immunodeficiency Syndrome-related products). The product was cleared in 1984 and is not reusable or MRI-compatible. Storage conditions are not specified in the data provided.
Other devices from Barnetts, Inc.
Questions
AI-generated answers, 19 Sep 2026
Are Ultra Shape Condoms reusable or designed for single-use only?
Ultra Shape Condoms are explicitly designed for single-use only. The product description confirms they are not intended to be reused, which is a standard safety practice for latex barrier contraceptives to prevent transmission of infections or damage to the condom material.
What materials are Ultra Shape Condoms made from, and how does this affect their use?
Ultra Shape Condoms are made from latex, a common material for condoms due to its durability and barrier properties. This material provides a physical barrier to prevent pregnancy and sexually transmitted infections during vaginal intercourse. However, users with latex allergies should avoid these condoms, as latex can cause allergic reactions in sensitive individuals.
Can Ultra Shape Condoms be used in an MRI machine, or are there any compatibility concerns?
Ultra Shape Condoms are not labeled as MRI-compatible in the provided data. While latex itself is generally non-ferromagnetic, it’s always best to confirm with the manufacturer before using any medical device in an MRI environment, as risks like heating or movement could still exist.
What sizes or models of Ultra Shape Condoms are available, and how do I determine the right fit?
The provided data does not specify exact sizes or models of Ultra Shape Condoms, but the product is listed under FDA classification 884.5300 for condoms. Typically, condoms come in standard sizes (e.g., small, medium, large) or measured by circumference. For the correct fit, users should refer to the manufacturer’s packaging or instructions, as sizing ensures proper protection and comfort.
How were Ultra Shape Condoms approved by the FDA, and what does this mean for their use?
Ultra Shape Condoms received FDA 510(k) clearance in 1984 under the HIS (Human Immunodeficiency Syndrome-related products) classification, meaning they were deemed *substantially equivalent* to a legally marketed predicate device. This clearance confirms their safety and effectiveness as a barrier contraceptive for preventing pregnancy and sexually transmitted infections during vaginal intercourse, adhering to FDA standards for obstetrics/gynecology use.