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U.S. Department of Health and Human Services

Product Classification

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Device condom, female, animal tissue
Regulation Description 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 CodeOBY
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type PMA
Regulation Number 884.5330
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible