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U.S. Department of Health and Human Services

Product Classification

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Device single-use internal condom
Regulation Description Single-use internal condom.
Definition For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded.
Physical State A single-use internal condom is a sheath-like device that lines the vaginal or anal wall and is inserted into the vagina or anus prior to the initiation of coitus.
Technical Method The device is inserted into the vagina or anus.
Target Area Vagina or anus
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeMBU
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.5340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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