Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5305](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5305) → QRZ — External Condom For Anal Intercourse Or Vaginal Intercourse

# QRZ · External Condom For Anal Intercourse Or Vaginal Intercourse

_Obstetrics/Gynecology · 21 CFR 884.5305 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/QRZ

## Overview

- **Product Code:** QRZ
- **Device Name:** External Condom For Anal Intercourse Or Vaginal Intercourse
- **Regulation:** [21 CFR 884.5305](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5305)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN210034](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/QRZ/DEN210034.md) | ONE Male Condom | Global Protection Corp. | Feb 23, 2022 | DENG |

## Top Applicants

- Global Protection Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/QRZ](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/QRZ)

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