LZL · Micro-Condom
Obstetrics/Gynecology · 21 CFR 884.5320 · Class 3
Overview
| Product Code | LZL |
|---|---|
| Device Name | Micro-Condom |
| Regulation | 21 CFR 884.5320 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
