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21 CFR 884.5460 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Obstetrical And Gynecological Devices (§ 884.1 To § 884.6200) — Obstetrical And Gynecological Therapeutic Devices (§ 884.5050 To § 884.5980) — Scented or scented deodorized menstrual tampon.

4 Aug 2016

(a) 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.

(b) Classification. Class II (performance standards).

21 CFR 884.5460
[45 FR 12684, Feb. 26, 1980, as amended at 45 FR 51186, Aug. 1, 1980]