MBUClass II

Single-Use Internal Condom

21 CFR 884.5340 / Obstetrics/Gynecology

MBU is the FDA product code for Single-Use Internal Condom, a class II device type, regulated under 21 CFR 884.5340. FDA's definition for this code reads: "For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: MBU
Device name: Single-Use Internal Condom
FDA definition: For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded.
Regulation: 21 CFR 884.5340
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code MBU

FDA records hold no clearances under product code MBU.

Recent recalls

Product code MBU

FDA records show no recalls under product code MBU.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)