Cleared Traditional

KY Grosz Jelly

K201186 · Rb Health (Us), LLC · Obstetrics & Gynecology

Jul 2020

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K201186 is an FDA 510(k) clearance for the KY Grosz Jelly, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by Rb Health (Us), LLC (Parsippany, US). The FDA issued a Cleared decision on July 30, 2020, 90 days after receiving the submission on May 1, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K201186 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2020
Decision Date	July 30, 2020
Days to Decision	90 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.