Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Medical specialty
Obstetrics/Gynecology
Device class
2
Regulation number
884.5300
Review panel
OB
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.