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Silicone Personal Lubricant ALL-IN-ONE

by United Consortium

510(k) K180083

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 NumberK180083 Date9 Apr 2018ClearedStatusActive

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  • Withdrawn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.

A silicone-based personal lubricant designed for penile, anal, and vaginal application. It is intended to lubricate and moisturize tissues to enhance comfort and ease during intimate sexual activity, while also supplementing natural bodily lubrication. Compatible with natural rubber latex, polyurethane, and polyisoprene condoms, it supports safe and effective use in various sexual contexts.

Supplied as a single-use product, the Silicone Personal Lubricant All-In-One is classified under product code NUC (Lubricant, Personal) and falls under FDA’s Class II regulatory category with special controls. Authorized via FDA 510(k) clearance (K180083) under the Obstetrics/Gynecology advisory committee, it adheres to regulation 884.5300. The device is intended for over-the-counter use and requires no additional sterilization beyond manufacturer packaging.

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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 Silicone Personal Lubricant All-In-One designed for?

    The Silicone Personal Lubricant All-In-One is designed to lubricate and moisturize tissues during intimate sexual activity. It enhances comfort and ease for penile, anal, and vaginal use by supplementing natural bodily lubrication, ensuring a smoother experience.

  • Is this lubricant compatible with condoms?

    Yes, this silicone-based lubricant is specifically formulated to be compatible with natural rubber latex, polyurethane, and polyisoprene condoms. This compatibility ensures safe and effective use without compromising condom integrity.

  • How is the Silicone Personal Lubricant All-In-One supplied?

    The Silicone Personal Lubricant All-In-One is supplied as a single-use product. It comes pre-packaged by the manufacturer, eliminating the need for additional sterilization beyond what is already provided in the packaging.

  • Is this lubricant reusable or intended for single-use?

    This lubricant is explicitly designed for single-use only. The manufacturer’s packaging ensures sterility and safety for one-time application, preventing cross-contamination or degradation of the product.

  • What regulatory approval does this lubricant have?

    The Silicone Personal Lubricant All-In-One holds FDA 510(k) clearance (K180083) under the Obstetrics/Gynecology advisory committee. It is classified under product code NUC (Lubricant, Personal) and falls under FDA’s Class II regulatory category with special controls, adhering to regulation 884.5300.