Lubricant, Personal

NUC · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.5300

Classification

FDA Product Code: NUC
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: Y

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.

Market data

Cleared 510(k) submissions: 240
Registered establishments: 116

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown