Cleared Traditional

Water-based Lubricant

K250142 · Global Protection Corp. · Obstetrics & Gynecology

Aug 2025

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K250142 is an FDA 510(k) clearance for the Water-based Lubricant, a Lubricant, Personal (Class II — Special Controls, product code NUC), submitted by Global Protection Corp. (Boston, US). The FDA issued a Cleared decision on August 8, 2025, 203 days after receiving the submission on January 17, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K250142 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2025
Decision Date	August 08, 2025
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement

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.