PEB

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Product code

PEB

Device name

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Device class

Class 2

21 CFR

21 CFR 884.5300

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

10 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).