MBU

Single-Use Internal Condom

Product code: MBU
Device name: Single-Use Internal Condom
Device class: Class 2
21 CFR: 21 CFR 884.5340
Medical specialty: Obstetrics/Gynecology
Marketing pathway: 510(K)

FDA classification definition

For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded.

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

Official FDA classification page: MBU

Classification and pathway per current FDA publications. Data from openFDA (CC0).