QRZ · Class II · 21 CFR 884.5305

FDA Product Code QRZ: External Condom For Anal Intercourse Or Vaginal Intercourse

An External Condom For Anal Intercourse Or Vaginal Intercourse Is A Barrier Device Which Covers The Penis And Is Used To Prevent The Transmission Of Sexually Transmitted Infections (when Used For Anal Intercourse Or Vaginal Intercourse) And For Contraception (when Used For Vaginal Intercourse). This Classification Does Not Include Condoms Intended For Vaginal Intercourse Only.

Leading manufacturers include Global Protection Corp..

1
Total
0
Cleared
181d
Avg days
2022
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared External Condom For Anal Intercourse Or Vaginal Intercourse Devices (Product Code QRZ)

1 devices
1–1 of 1
Not Cleared Feb 23, 2022
ONE Male Condom
DEN210034
Global Protection Corp.
Obstetrics & Gynecology · 181d

About Product Code QRZ - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QRZ since 2022, with 0 receiving FDA clearance (average review time: 181 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

QRZ devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →