C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES › Subpart F—Obstetrical and Gynecological Therapeutic Devices

21 C.F.R. § 884.5470

Unscented menstrual tampon

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(a) 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.

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

Notes of Decisions
Cited in 2 cases, 1987–1990 · leading case: Stewart v. Int'l Playtex, Inc., 672 F. Supp. 907 (D.S.C. 1987).
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Stewart v. Int'l Playtex, Inc., 672 F. Supp. 907 (D.S.C. 1987). “5460 and 21 C.F.R. Section 884.5470. 2. Following almost two years (October 1980 to June 1982) of notice, study and comment with a complete analysis and review of all scientific evidence relating to tampons and TSS, the FDA promulgated a regulation requiring that specific…”
Berger v. Pers. Prods., Inc., 797 P.2d 1148 (Wash. 1990). “5460 ; 21 C.F.R § 884.5470 (1988). 5 (Italics ours.”
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