Cleared Traditional

Astroglide Warming

K221036 · Biofilm, Inc. · Obstetrics & Gynecology

Jul 2022

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K221036 is an FDA 510(k) clearance for the Astroglide Warming, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by Biofilm, Inc. (Vista, US). The FDA issued a Cleared decision on July 1, 2022, 85 days after receiving the submission on April 7, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K221036 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 2022
Decision Date	July 01, 2022
Days to Decision	85 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.