Product code NUC

Device name

Lubricant, Personal

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

Y

Summary malfunction reporting

Eligible

Definition

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

Source

FDA openFDA device classification dataset