QRZ

External Condom For Anal Intercourse Or Vaginal Intercourse

Product code

QRZ

Device name

External Condom For Anal Intercourse Or Vaginal Intercourse

Device class

Class 2

21 CFR

21 CFR 884.5305

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

An external condom for anal intercourse or vaginal intercourse is a barrier device which covers the penis and is used to prevent the transmission of sexually transmitted infections (when used for anal intercourse or vaginal intercourse) and for contraception (when used for vaginal intercourse). This classification does not include condoms intended for vaginal intercourse only.

Definition text from the FDA device classification database (U.S. federal government work, public domain).