---
kind: "section"
citation: "21 C.F.R. § 884.5350"
title: "21"
number: "884.5350"
heading: "Contraceptive diaphragm and accessories."
url: "https://uscodex.org/cfr/21/884.5350"
---

# §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).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.