Tampon, Menstrual, Scented-Deodorized, Original Regular
by Tambrands Inc. 510(k)
Active
510(k) K872256
Overview
This device is a menstrual tampon designed for vaginal insertion during menstruation. It features a scented-deodorized formulation to help reduce odor associated with menstrual flow, providing comfort and hygiene for users. Classified under the FDA’s product code HIL, it falls within Class II medical devices, subject to special controls for safety and performance.
The Tampon, Menstrual, Scented-Deodorized, Original Regular is intended for single-use and is not sterile at the point of sale. It is regulated under FDA 510(k) clearance (K872256) with a decision of Substantially Equivalent, issued in 1987. No MRI safety or reusable specifications are noted, and compliance with regulation 884.5460 applies. Users should follow manufacturer instructions for proper insertion and disposal.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872256 | Date10 Jul 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- Full name
- Tampax Deodorant Tampon, Original Regular
- 510(k) Number
- FDA Product Code
- HIL
- FDA applicant
- Tambrands, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5460
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tambrands Inc.
Questions
What is the Tampon, Menstrual, Scented-Deodorized, Original Regular used for?
This device is designed for vaginal insertion during menstruation to absorb menstrual flow. The scented-deodorized formulation helps reduce odor associated with menstrual bleeding, providing added comfort and hygiene for users.
Is the Tampon, Menstrual, Scented-Deodorized, Original Regular sterile?
No, this tampon is not sterile at the point of sale. It is intended for single-use only and should not be reused or sterilized. Always follow the manufacturer’s instructions for proper use.
What regulatory approval does this tampon have?
This product holds FDA 510(k) clearance (K872256) under the product code HIL, classified as a Class II medical device. It was determined to be substantially equivalent in 1987 and complies with regulation 884.5460.
Are there different sizes or models available for this tampon?
Yes, this tampon is available in multiple registration numbers (e.g., 3014833751, 3012118920), which may correspond to different packaging or batch variations. The ‘Original Regular’ refers to its standard size and formulation, but additional sizes or variants may exist under different registration identifiers.
How should this tampon be stored?
Store in a cool, dry place away from direct sunlight. Ensure the packaging remains intact until use to maintain hygiene and effectiveness. Do not expose to extreme temperatures or moisture.