FREE CHOICE
Device Facts
| Record ID | K963032 |
|---|---|
| Device Name | FREE CHOICE |
| Applicant | First Quality Hygienic, Inc. |
| Product Code | HEB · Obstetrics/Gynecology |
| Decision Date | Oct 11, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5470 |
| Device Class | Class 2 |
Intended Use
Femtex Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Device Story
Menstrual tampon; non-applicator design; inserted into vagina to absorb menstrual fluid. Available in regular, super, and super plus absorbencies. Used by individuals during menstruation. Device functions via physical absorption of fluid.
Clinical Evidence
Bench testing only. Biocompatibility testing performed including irritation, sensitization, cytotoxicity, and vaginal irritation testing. Absorbency verified via standard Syngyna testing. No clinical data presented.
Technological Characteristics
Materials: rayon, polyethylene, polypropylene overwrap, cotton cord. Form factor: digital (non-applicator) tampon. Absorbency: regular, super, super plus. Testing: Syngyna standard.
Indications for Use
Indicated for use by menstruating individuals 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 (K963032)
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