FEMTEX GENTLE TOUCH TAMPONS
Device Facts
| Record ID | K963034 |
|---|---|
| Device Name | FEMTEX GENTLE TOUCH TAMPONS |
| Applicant | First Quality Hygienic, Inc. |
| Product Code | HEB · Obstetrics/Gynecology |
| Decision Date | Nov 1, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5470 |
| Device Class | Class 2 |
Intended Use
Femtex Gentle Touch tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Device Story
Menstrual tampons; rayon and cotton construction; cotton cord and sewing thread. Used for absorption of menstrual fluid. Inserted into vagina. Available in regular, super, and super plus absorbencies. Intended for use by females during menstruation.
Clinical Evidence
Bench testing only. Biocompatibility testing (irritation, sensitization, vaginal irritation) and Syngyna absorbency testing performed. Results demonstrate safety and effectiveness equivalent to legally marketed tampons.
Technological Characteristics
Materials: rayon, cotton, cotton cord, sewing thread. Absorbency tested via standard Syngyna method. No electronic or software components.
Indications for Use
Indicated for females requiring absorption of menstrual fluid. No specific age or contraindications provided.
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
- K971228 — FEMTEX 100% COTTON TAMPONS · Regu-Tech Assoc., Inc. · Apr 9, 1997
- K970232 — FEMTEX 100% COTTON DENTLE TOUCH TAMPONS · Regu-Tech Assoc., Inc. · Mar 21, 1997
- K983381 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS · Paragon Trade Brands, Inc. · Oct 19, 1998
- K050067 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS · First Quality Hygienic, Inc. · Feb 1, 2005
- K062638 — TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS · Procter & Gamble Co. · Nov 22, 2006
