Device |
external condom for anal intercourse or vaginal intercourse |
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. |
Physical State |
Natural rubber latex sheath |
Technical Method |
Barrier device that covers the penis during anal or vaginal intercourse |
Target Area |
Penis, vagina, anus |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Obstetrics/Gynecology |
Product Code | QRZ |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
884.5305
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|