PEB — Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible Class II

FDA Device Classification

Classification Details

Product Code
PEB
Device Class
Class II
Regulation Number
884.5300
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K212885cc wellnessActively Trying Personal Lubricant Rose ScentedFebruary 11, 2022
K212705cc wellnessActively Trying Personal Lubricant UnfragranceFebruary 9, 2022
K193450church and dwight coPre-Seed™ Fertility LubricantJuly 23, 2020
K190872good clean loveBioGenesis Fertility LubricantNovember 7, 2019
K182585united consortiumJO Actively Trying Personal LubricantApril 26, 2019
K162319fairhaven healthBabyDance Fertility LubricantApril 28, 2017
K141132biofilmASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANTJanuary 9, 2015
K131355sasmarCONCEIVE PLUSNovember 7, 2013
K072741ingfertilityPRE-VA VAGINAL LUBRICANTJuly 16, 2008
K051436ingfertlityPRE' VAGINAL LUBRICANTOctober 13, 2006