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Sylk Personal Lubricant

by Toro Management, LLC Dba Sylk

510(k) K152646

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 NumberK152646 Date11 Mar 2016ClearedStatusActive

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  • Withdrawn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 Sylk Personal Lubricant is a Lubricant, Personal (NUC classification), designed to provide hydration and reduce friction during intimate activities. It is formulated to be compatible with latex and non-latex condoms, ensuring safe use. The product is intended for vaginal and anal use, offering a water-based solution that mimics natural lubrication.

Supplied as a single-use, sterile, pre-filled applicator, the lubricant is intended for home or clinical use in obstetrics and gynecology settings. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance as substantially equivalent to predicate devices. Storage requires protection from extreme temperatures and direct sunlight, and the product must be discarded after single use to maintain sterility.

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 Sylk Personal Lubricant, and where can it be used?

    The Sylk Personal Lubricant is designed to provide hydration and reduce friction during intimate activities, mimicking natural lubrication. It is intended for both vaginal and anal use and can be safely used in home settings or clinically in obstetrics and gynecology environments.

  • Is the Sylk Personal Lubricant compatible with condoms, and if so, which types?

    Yes, the Sylk Personal Lubricant is specifically formulated to be compatible with both latex and non-latex condoms, ensuring safe use without compromising barrier protection.

  • How is the Sylk Personal Lubricant supplied, and is it reusable?

    The lubricant is supplied as a single-use, sterile, pre-filled applicator. It must be discarded after one use to maintain sterility, so it is not intended for reuse.

  • What storage conditions are required for the Sylk Personal Lubricant?

    The product should be stored in a location protected from extreme temperatures and direct sunlight to preserve its integrity and effectiveness.

  • What regulatory pathway was followed for the Sylk Personal Lubricant’s approval?

    The Sylk Personal Lubricant received FDA 510K clearance through a traditional review process, demonstrating it is substantially equivalent to predicate devices. It is classified as a Class II medical device under FDA regulations.