Cleared Traditional

BioNude Lubricant

K180136 · Good Clean Love, Inc. · Obstetrics & Gynecology

Jun 2018

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K180136 is an FDA 510(k) clearance for the BioNude Lubricant, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by Good Clean Love, Inc. (Eugene, US). The FDA issued a Cleared decision on June 1, 2018, 135 days after receiving the submission on January 17, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K180136 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2018
Decision Date	June 01, 2018
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	NUC — Lubricant, Personal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5300
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.