Unscented Menstrual Tampon, Plastic Applicator
by Tambrands Inc. 510(k)
Active
510(k) K962476
Overview
An unscented menstrual tampon with plastic applicator is a device intended to absorb menstrual fluid. It consists of rayon fibers, an overwrap, a cotton withdrawal cord, and a colored plastic applicator.
It is available in regular, super, and super plus absorbencies and is used by women during menstruation. The device functions via physical absorption, with the applicator facilitating insertion. It is supplied as a single-use device and has received FDA 510(k) clearance under K962476, with product code HEB and regulation number 884.5470.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962476 | Date13 Aug 1996 | 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- Withdrawn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
- HEB
- FDA applicant
- Tambrands, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5470
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tambrands Inc.
Questions
What is the unscented menstrual tampon with plastic applicator used for?
It is intended to absorb menstrual fluid during menstruation, functioning through physical absorption of rayon fibers and overwrap, with the plastic applicator facilitating insertion.
How is the unscented menstrual tampon with plastic applicator supplied and is it reusable?
It is supplied as a single-use device, meaning each tampon and applicator is intended for one insertion and removal cycle, then discarded to maintain hygiene and prevent cross-contamination.
What absorbencies are available for the unscented menstrual tampon with plastic applicator?
The device is available in three absorbency levels: regular, super, and super plus, allowing users to select based on their menstrual flow needs.
What regulatory clearance does the unscented menstrual tampon with plastic applicator have?
It has received FDA 510(k) clearance under submission number K962476, classified under product code HEB and regulation number 884.5470, confirming substantial equivalence to a legally marketed device.