FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
Device Facts
| Record ID | K970232 |
|---|---|
| Device Name | FEMTEX 100% COTTON DENTLE TOUCH TAMPONS |
| Applicant | Regu-Tech Assoc., Inc. |
| Product Code | HEB · Obstetrics/Gynecology |
| Decision Date | Mar 21, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5470 |
| Device Class | Class 2 |
Intended Use
Femtex 100% Cotton Gentle Touch tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Device Story
Menstrual tampons; inserted into vagina to absorb menstrual fluid. Composed of cotton absorbent, cotton cord, and cotton sewing thread. Available in regular and super absorbencies. Used by patients for menstrual hygiene management.
Clinical Evidence
Bench testing only. Biocompatibility testing performed including irritation, cytotoxicity, sensitization, and vaginal irritation testing. Syngyna testing conducted to confirm absorbency performance. Results demonstrate safety and effectiveness equivalent to legally marketed tampons.
Technological Characteristics
Materials: 100% cotton absorbent, cotton cord, cotton sewing thread. Form factor: tampon with applicator. Absorbency: regular and super. No electronic or software components.
Indications for Use
Indicated for females of menstruating age 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 Gentle Touch tampons
Related Devices
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- K963034 — FEMTEX GENTLE TOUCH TAMPONS · First Quality Hygienic, Inc. · Nov 1, 1996
- K253719 — Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons · Unibeauty (Hubei) Technology Co., Ltd. · Dec 17, 2025
- K971228 — FEMTEX 100% COTTON TAMPONS · Regu-Tech Assoc., Inc. · Apr 9, 1997
- K023479 — FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES · First Quality Hygienic, Inc. · Nov 26, 2002
