21 CFR 884.5460 — Tampon, Menstrual, Scented, Scented-Deodorized

Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5460

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.

Classification Rationale

Class II (performance standards).

Product Codes