• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device lubricant, personal, gamete, fertilization, and embryo compatible
Regulation Description Condom.
Definition A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication.This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive.This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.
Physical State Liquid or gel
Technical Method Coats vaginal and/or penile tissue to reduce friction during sexual activity with or without a condom; is non-toxic to sperm, oocytes, and developing embryos and does not interfere with the fertilization process; lubricates devices used during fertility interventions.
Target Area Vagina and/or penis
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePEB
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.5300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
-
-