Product code QRZ— Obstetrics/Gynecology

ONE Male Condom

Classification name: External Condom For Anal Intercourse Or Vaginal Intercourse
Device class: Class 2
Regulation: 21 CFR 884.5305
Advisory panel: Obstetrics/Gynecology
Total cleared: 1
First cleared: 2022-02-23
Most recent: 2022-02-23

FDA classification definition

“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.”
— U.S. Food and Drug Administration, device classification record for product code QRZ under 21 CFR 884.5305, via openFDA

Market context for product code QRZ

FDA has cleared 1 device under product code QRZ, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QRZ

Global Protection Corp.1 clearance

Recent clearances under product code QRZ

DEN210034 — ONE Male CondomGlobal Protection Corp.·2022-02-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.