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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOBY
Regulation Number 884.5330
Device Class 3