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§ 884.5350 Contraceptive diaphragm and accessories.

21 CFR 884.5350

Citation21 CFR 884.5350
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 884.5350 Contraceptive diaphragm and accessories.

(a) Identification. A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.

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