Skip to content

O Glide Personal Lubricant

by Grafenberg Labs

510(k) K142726

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142726 Date24 Jul 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NUC
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The O Glide Personal Lubricant is a Lubricant, Personal (per FDA nomenclature), designed to supplement natural lubrication and enhance comfort during intimate sexual activity. Formulated as an oil-based solution, it is intended for topical application to the penis or vagina.

Supplied in a low-density polyethylene (LDPE) plastic tube, the device is non-sterile and intended for over-the-counter use. It falls under FDA classification II (Class 2) and was granted FDA 510(k) clearance under regulation 884.5300, with a decision of Substantially Equivalent (SE) by the Obstetrics/Gynecology advisory committee in 2015.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the O Glide Personal Lubricant, and how is it intended to be used?

    The O Glide Personal Lubricant is designed to supplement natural lubrication and enhance comfort during intimate sexual activity. It is formulated as an oil-based solution for topical application to the penis or vagina, providing a smooth and comfortable experience.

  • Is the O Glide Personal Lubricant sterile, and how is it packaged for use?

    The O Glide Personal Lubricant is not sterile and is supplied in a low-density polyethylene (LDPE) plastic tube, intended for over-the-counter use. This packaging ensures ease of access for consumers without requiring medical sterilization.

  • How is this lubricant classified by the FDA, and what does that mean for its regulatory status?

    The O Glide Personal Lubricant is classified as a Class II medical device under FDA regulations (884.5300) and was granted 510(k) clearance in 2015. This classification indicates it is subject to special controls to ensure safety and effectiveness, but it is still available for over-the-counter purchase, as it does not require a prescription.

  • Are there multiple sizes or models of the O Glide Personal Lubricant, or is it available in a single formulation?

    The provided data does not specify multiple sizes or models of the O Glide Personal Lubricant. It is described as a single formulation supplied in a standard LDPE tube, with no variations in volume or formulation mentioned.

  • What storage instructions should be followed for the O Glide Personal Lubricant?

    While the data does not explicitly detail storage conditions, typical oil-based lubricants like this are generally recommended to be stored in a cool, dry place away from direct sunlight. Since it is non-sterile and over-the-counter, it should be kept out of reach of children and handled with standard hygiene precautions.