Cleared Traditional

Grosz Play Feel

K211088 · Rb Health (Us), LLC · Obstetrics & Gynecology

Jul 2021

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K211088 is an FDA 510(k) clearance for the Grosz Play Feel, 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 9, 2021, 88 days after receiving the submission on April 12, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K211088 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2021
Decision Date	July 09, 2021
Days to Decision	88 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.