Device |
condom, female, animal tissue |
Regulation Description |
Multiple-use female condom. |
Definition |
A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes. |
Physical State |
A sheath like device made from animal tissue, with retention mechanisms as to stay in place during coitus. |
Technical Method |
Provides a thin film barrier to sperm and std microorganisms. |
Target Area |
vagina |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Obstetrics/Gynecology |
Product Code | OBY |
Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
PMA
|
Regulation Number |
884.5330
|
Device Class |
3
|
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 |