# Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
> **Product code: PEB** · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.5300
## Classification
- **FDA Product Code:** PEB
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 884.5300
- **Review panel:** OB
- **Medical specialty:** Obstetrics/Gynecology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 10
- **Registered establishments:** 11
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PEB)
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