884.5350 Contraceptive diaphragm and accessories.§ 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).