External Condom For Anal Intercourse Or Vaginal Intercourse
QRZ · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.5305
Classification
FDA Product Code
QRZ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 884.5305
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.