21 CFR § 884.5350 Obstetrical and Gynecological Devices

§ 884.5350 Contraceptive diaphragm and accessories.

Current through Sep 8, 2026 · Read all of Part 884

(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).

← § 884.5340 Single-use internal condom.§ 884.5360 Contraceptive intrauterine device (IUD) and introducer. →