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U.S. Department of Health and Human Services

Medical Devices

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FC2 Female Condom - P080002

FC2 Female Condom

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

 


Product Name: FC2 Female Condom
PMA Applicant:The Female Health Company (FHC)
Address: 515 North State St., Suite 2225, Chicago, IL 60610
Approval Date: March 10, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080002a.pdf

What is it? The FC2 female condom is a sheath with one open end. There is an outer ring at the open end, and, although not attached to the condom, there is an inner ring inside the sheath that aids in insertion.

How does it work? The FC2 female condom is inserted into the vagina before intercourse, and it is a barrier to sperm between the penis and the vagina. It reduces access of semen to the vagina, and, thereby prevents or decreases the rate of pregnancy compared to unprotected intercourse. Also, the condom barrier prevents access to the vagina of pathogenic bacteria and viruses in secretions as well as contact between lesions on the shaft of the penis and the vagina.

When is it used? The FC2 female condom is inserted into the vagina before, and in place during, sexual intercourse.

What will it accomplish?The device helps to prevent HIV/AIDS, other sexually transmitted infections (STIs) and unintended pregnancy.

When should it not be used? There are no contraindications for the FC2 Female Condom.

Additional information: The Summary of Safety and Effectiveness and Labeling will be available online.