MBU — Single-Use Internal Condom Class II

FDA Device Classification

Classification Details

Product Code: MBU
Device Class: Class II
Regulation Number: 884.5340
Submission Type
Review Panel: OB
Medical Specialty: Obstetrics/Gynecology
Implant: No

Definition

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