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Pjur Original, Pjur Woman, Pjur Man Extreme Glide

by Pjur Group Luxembourg S.A.

510(k) K133233

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 NumberK133233 Date18 Jul 2014ClearedStatusActive

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  • Withdrawn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, 22 Sep 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 personal lubricant intended for penile and/or vaginal application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

The product is supplied as a non-sterile, single-use or reusable topical lubricant for over-the-counter use in personal or clinical settings. It is regulated as a Class II medical device under FDA 510(k) clearance K133233, with product code NUC and regulation number 884.5300, and is substantially equivalent to legally marketed personal lubricants.

Other devices from Pjur Group Luxembourg S.A.

Questions

AI-generated answers, 22 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 Pjur Original Woman Man Extreme Glide intended for?

    This device is a personal lubricant intended for penile and/or vaginal application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.

  • Is Pjur Original Woman Man Extreme Glide sterile or non-sterile, and is it single-use or reusable?

    The product is supplied as a non-sterile, single-use or reusable topical lubricant for over-the-counter use in personal or clinical settings.

  • What types of condoms is Pjur Original Woman Man Extreme Glide compatible with?

    It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.