Tampon, Menstrual, Unscented, Plastic, Tampax L
by Procter & Gamble Co. 510(k)
Active
510(k) K131543
Overview
This device is a menstrual tampon designed for vaginal insertion to absorb menstrual fluid. Classified as a Class II medical device under FDA regulations, it is intended for use during menstruation to provide comfort and hygiene. The tampon features a plastic applicator for ease of insertion and is available in an unscented formulation.
Tampons are single-use, non-sterile products supplied in individual packaging for home or clinical use. They are regulated under FDA’s 510(k) clearance process (K131543) and fall under the Obstetrics/Gynecology specialty category. The device is available in a standard size (L) and must be stored according to manufacturer guidelines to maintain integrity. No MRI safety considerations apply, as the plastic material is non-metallic.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131543 | Date20 Jun 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Full name
- Tampax(R) L Plastic Tampons, Unscented
- 510(k) Number
- FDA Product Code
- HEB
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5470
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Procter & Gamble Co.
Questions
What is the Tampax L Plastic Tampon, Unscented, used for?
The Tampax L Plastic Tampon, Unscented, is designed for vaginal insertion during menstruation to absorb menstrual fluid. It provides comfort and maintains hygiene, making it suitable for daily use when managing heavy or regular menstrual flow. The plastic applicator helps ensure easy and clean insertion.
How is the Tampax L Plastic Tampon, Unscented, supplied and stored?
This tampon is supplied in individual, non-sterile packaging for single-use only. Each tampon comes with a plastic applicator for ease of insertion. To maintain its integrity, store the tampons in a cool, dry place, away from direct sunlight and moisture. Follow the manufacturer’s guidelines to ensure the product remains effective and safe for use.
Is the Tampax L Plastic Tampon, Unscented, reusable or single-use?
The Tampax L Plastic Tampon, Unscented, is intended for single-use only. After insertion, it should be discarded to prevent contamination and maintain hygiene. Reusing tampons can pose health risks, such as bacterial growth or irritation, so it is not recommended.
What size is the Tampax L Plastic Tampon, Unscented, and are there other sizes available?
The Tampax L Plastic Tampon, Unscented, is available in the standard size L, which is designed for moderate to heavy menstrual flow. While this is the primary size offered for this specific product, other sizes (e.g., Regular, Super, or Super Plus) may be available under the Tampax brand. Always check the packaging or product details for size variations.
Can the Tampax L Plastic Tampon, Unscented, be used safely in an MRI machine?
No MRI safety considerations apply to the Tampax L Plastic Tampon, Unscented, as it is made from non-metallic plastic material. This means it is safe to use if an MRI scan is required, as there is no risk of interference or injury from magnetic fields. Always confirm with your healthcare provider before undergoing an MRI if you have any concerns.