Product Classification

• 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 Code: MBU
• 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
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 9-67 ASTM D7661-10 (Reapproved 2017)
  Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
• 9-116 ISO 29943-2 First edition 2017-07
  Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports.
• 9-122 ISO 25841 Third edition 2017-08
  Female condoms -- Requirements and test methods
• 9-145 ASTM D7661-18
  Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

Third Party Review

Not Third Party Eligible