Tampon, Menstrual, Scented-Deodorized, Petal Soft Super
by Tambrands Inc. 510(k)
Active
510(k) K872259
Overview
This device is a menstrual tampon designed for vaginal insertion during menstruation. It features a scented-deodorized formulation to help reduce odor, providing comfort and hygiene for the user. The tampon is constructed with a soft, absorbent material to manage menstrual flow effectively while maintaining a gentle fit.
The Petal Soft Super tampon is intended for single-use and requires no sterilization. It is classified under product code HIL and falls under FDA 510(k) clearance (K872259) as a Class II device with special controls. Supplied in sterile packaging, it is regulated under 21 CFR 884.5460 and is intended for internal vaginal use only. No additional storage requirements beyond standard room temperature are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872259 | 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- Withdrawn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 6 Oct 2026.
Specification
- Full name
- Tampax Petal Soft Deodorant Tampon, Super
- 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 Tampax Petal Soft Super Deodorant Tampon designed for?
This tampon is specifically designed for vaginal insertion during menstruation to manage menstrual flow effectively. Its scented-deodorized formulation helps reduce odor, providing added comfort and hygiene for users. The soft, absorbent material ensures a gentle fit while maintaining optimal absorption.
How is the Tampax Petal Soft Super Deodorant Tampon supplied and prepared for use?
The tampon is supplied in sterile packaging, ensuring it is ready for immediate use without additional sterilization. Each tampon is intended for single-use only, meaning it should not be reused after insertion. The sterile packaging maintains its cleanliness until the moment of use.
Is the Tampax Petal Soft Super Deodorant Tampon reusable or single-use?
This tampon is explicitly designed for single-use only. After insertion and removal, it should be discarded to maintain hygiene and prevent contamination. Reusing a tampon increases the risk of irritation, infection, or discomfort due to bacterial buildup.
Are there any special storage requirements for the Tampax Petal Soft Super Deodorant Tampon?
No special storage requirements are specified beyond standard room temperature. The tampon should be stored in a cool, dry place, away from direct sunlight or moisture, to preserve its sterility and effectiveness until use. Always check the packaging for any additional instructions before storage.
What regulatory approval does the Tampax Petal Soft Super Deodorant Tampon hold?
The Tampax Petal Soft Super Deodorant Tampon is cleared by the FDA under the 510(k) pathway (K872259) as a Class II device with special controls. It is regulated under 21 CFR 884.5460 and is intended exclusively for internal vaginal use. The clearance confirms it meets FDA standards for safety and effectiveness.