PLAYTEX NON-DEODORANT/DEODORANT TAMPONS
Device Facts
| Record ID | K912002 |
|---|---|
| Device Name | PLAYTEX NON-DEODORANT/DEODORANT TAMPONS |
| Applicant | Playtex Family Products, Inc. |
| Product Code | HIL · Obstetrics/Gynecology |
| Decision Date | Aug 12, 1991 |
| 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.
