Personal Lubricant Ring

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

Classification

FDA Product Code: QPD
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

This device is a personal lubricant, for 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, polyurethane, and/or internal condoms.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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