Skip to content

Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse Me!

by Pjur Group Luxembourg S.A.

510(k) K141913

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 NumberK141913 Date6 Apr 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  • Withdrawn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, 1 Oct 2026

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

This device is a silicone-based lubricant designed for anal intercourse. It is formulated to provide prolonged lubrication and skin conditioning, incorporating jojoba oil to nourish and moisturize the anal area, thereby promoting elasticity and reducing friction during penetration.

The lubricant is intended for single-use and is supplied in sterile, pre-packaged applicators. It is classified as a Class II medical device under FDA regulations (884.5300) and has received FDA 510K clearance as substantially equivalent. The product is non-reusable and does not require sterilization beyond its original packaging. No MRI safety information is specified, and it is not intended for use in sterile surgical settings.

Other devices from Pjur Group Luxembourg S.A.

Questions

AI-generated answers, 1 Oct 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 PJUR Backdoor Anal Glide Lubricant designed for?

    The PJUR Backdoor Anal Glide Lubricant is specifically formulated for anal intercourse. It combines silicone-based lubrication with jojoba oil to provide prolonged moisture and skin conditioning, enhancing elasticity and reducing friction during penetration. This helps promote a smoother and more comfortable experience.

  • How is the lubricant supplied, and is it sterile?

    The lubricant is supplied in sterile, pre-packaged applicators, ensuring it is ready for single-use without additional sterilization. This packaging maintains sterility and hygiene, making it convenient for immediate use.

  • Is the PJUR Backdoor Anal Glide Lubricant reusable?

    No, the lubricant is designed for single-use only. Each applicator is intended to be used once and then discarded. This design ensures hygiene and prevents cross-contamination between uses.

  • What makes the lubricant’s formulation unique?

    The lubricant’s formulation includes silicone-based ingredients combined with jojoba oil, which nourishes and moisturizes the anal area. This blend helps maintain prolonged lubrication and skin elasticity, reducing irritation and friction during use.

  • How should the lubricant be stored?

    The lubricant should be stored according to the manufacturer’s instructions on the packaging. Since it is supplied in sterile, pre-packaged applicators, it is important to keep the applicators sealed until use to preserve sterility and prevent contamination.