Sheer Thin
by Twe Companies, Inc. 510(k)
Active
510(k) K984488
Overview
Sheer Thin is a condom, a barrier contraceptive device designed to prevent pregnancy and sexually transmitted infections by providing a physical barrier between partners during sexual intercourse. It is classified as a Class 2 medical device under FDA regulations, intended for use in obstetrics and gynecology-related contexts, though its primary function remains contraception.
The device is supplied as a single-use product and is regulated under FDA clearance (K984488) via the Traditional 510(k) pathway. It is not described as sterile in the provided data, nor are MRI safety or reusable specifications mentioned. The product code HIS aligns with obstetrics/gynecology-related submissions, though this does not imply clinical use beyond its intended contraceptive purpose. Storage and handling instructions are not specified in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK984488 | Date1 Feb 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Questions
What is the Sheer Thin condom used for?
The Sheer Thin condom is a barrier contraceptive device designed to prevent pregnancy and sexually transmitted infections (STIs) by creating a physical barrier between partners during sexual intercourse. While classified under FDA regulations as a Class 2 medical device with a product code for obstetrics/gynecology (HIS), its primary and intended purpose remains contraception.
Is the Sheer Thin condom sterile?
The provided data does not specify whether the Sheer Thin condom is sterile. If sterility is a critical requirement for your use case, it is recommended to verify this directly with the manufacturer, Twe Companies, Inc.
How is the Sheer Thin condom supplied and intended for use?
The Sheer Thin condom is supplied as a single-use product. This means each condom is intended for one-time use only and should not be reused. The device is regulated under the FDA’s Traditional 510(k) pathway, with clearance number K984488, ensuring it meets regulatory standards for safety and effectiveness.
Are there different sizes or models of the Sheer Thin condom?
The provided data does not detail specific sizes or models of the Sheer Thin condom. However, the device is listed under multiple registration numbers in the FDA database, which may correspond to variations or lot-specific identifiers. For precise sizing or model-specific information, contact Twe Companies, Inc. directly.
What storage instructions apply to the Sheer Thin condom?
The data does not include explicit storage instructions for the Sheer Thin condom. Proper storage typically involves keeping condoms in a cool, dry place away from direct sunlight and extreme temperatures. If specific storage requirements are critical for your application, consult the manufacturer’s guidelines or packaging for detailed recommendations.