21 CFR 884.5320 — Micro-Condom

Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5320

Identification

A glans sheath device is a sheath which covers only the glans penis or part thereof and may also cover the area in the immediate proximity thereof, the corona and frenulum, but not the entire shaft of the penis. It is indicated only for the prevention of pregnancy and not for the prevention of sexually-transmitted diseases.

Classification Rationale

Class III (premarket approval).

Product Codes

Product CodeDevice NameClassDevicesAttributes
LZLMicro-Condom30
Innolitics

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