PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS
Device Facts
| Record ID | K904937 |
|---|---|
| Device Name | PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS |
| Applicant | Playtex Family Products, Inc. |
| Product Code | HEB · Obstetrics/Gynecology |
| Decision Date | Mar 15, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5470 |
| Device Class | Class 2 |
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.
