FEMTEX 100% COTTON TAMPONS
Device Facts
| Record ID | K971228 |
|---|---|
| Device Name | FEMTEX 100% COTTON TAMPONS |
| Applicant | Regu-Tech Assoc., Inc. |
| Product Code | HEB · Obstetrics/Gynecology |
| Decision Date | Apr 9, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5470 |
| Device Class | Class 2 |
Intended Use
Femtex tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Device Story
Menstrual tampon; cotton construction with cotton cord and sewing thread; regular and super absorbencies; inserted into vagina to absorb menstrual fluid; intended for consumer self-use.
Clinical Evidence
Bench testing only. Biocompatibility testing (cytotoxicity) and Syngyna absorbency testing performed. Review of existing toxicological data from public literature.
Technological Characteristics
Materials: 100% cotton, cotton cord, sewing thread. Form factor: menstrual tampon. Absorbency levels: regular, super.
Indications for Use
Indicated for use by females for the absorption of menstrual fluid.
Regulatory Classification
Identification
An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.
Predicate Devices
- Femtex tampons with applicators
Related Devices
- K963034 — FEMTEX GENTLE TOUCH TAMPONS · First Quality Hygienic, Inc. · Nov 1, 1996
- K970232 — FEMTEX 100% COTTON DENTLE TOUCH TAMPONS · Regu-Tech Assoc., Inc. · Mar 21, 1997
- K963032 — FREE CHOICE · First Quality Hygienic, Inc. · Oct 11, 1996
- K983381 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS · Paragon Trade Brands, Inc. · Oct 19, 1998
- K062638 — TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS · Procter & Gamble Co. · Nov 22, 2006
