PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED
Device Facts
| Record ID | K940821 |
|---|---|
| Device Name | PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED |
| Applicant | Playtex Family Products, Inc. |
| Product Code | HIL · Obstetrics/Gynecology |
| Decision Date | Mar 25, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5460 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.
