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QRZClass II

External Condom For Anal Intercourse Or Vaginal Intercourse

21 CFR 884.5305 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

QRZ is the FDA product code for External Condom For Anal Intercourse Or Vaginal Intercourse, a class II device type, regulated under 21 CFR 884.5305. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QRZ
Device name
External Condom For Anal Intercourse Or Vaginal Intercourse
FDA 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.
Regulation
21 CFR 884.5305
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QRZ

By decision year
1 clearance under product code QRZ with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QRZ by decision year
YearClearances
20221

Applicants with the most clearances

Product code QRZ
Applicants holding the most 510(k) clearances under product code QRZ
ApplicantClearances
Global Protection Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code