Cleared Traditional

ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT

K141132 · Biofilm, Inc. · Obstetrics & Gynecology

Jan 2015

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K141132 is an FDA 510(k) clearance for the ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT, a Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible (Class II — Special Controls, product code PEB), submitted by Biofilm, Inc. (Vista, US). The FDA issued a Cleared decision on January 9, 2015, 253 days after receiving the submission on May 1, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K141132 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2014
Decision Date	January 09, 2015
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	PEB — Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5300
Definition	A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Sexual Activity And Supplement The Body's Natural Lubrication. This Device May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms. This Device Is Compatible With Sperm, Oocytes, And Embryos And Can Be Used By Couples Trying To Conceive. This Device May Also Be Used During Fertility Interventions To Facilitate Entry Of Diagnostic And Therapeutic Devices.