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O'My Natural Lubricant, O'My Natural Flavored Lubricant

by O'My Products Incorporated

510(k) K042915

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 NumberK042915 Date31 Aug 2005ClearedStatusActive

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  • Withdrawn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.

O'My Natural Lubricant and O'My Natural Flavored Lubricant are water-based, non-sterile personal lubricants designed to supplement natural body fluids, reduce friction, and enhance comfort during intimate activity. They are compatible with latex condoms and function as a physical lubricant with no active electronic or mechanical components.

These lubricants are used by consumers in home settings and applied topically to body orifices. The device is classified as a personal lubricant with product code NUC and has FDA 510K clearance with K number K042915. The device is non-sterile and available in multiple sizes as indicated by the various registration numbers provided.

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 purpose of O'My Natural Lubricant?

    O'My Natural Lubricant is a water-based personal lubricant designed to supplement natural body fluids, reduce friction, and enhance comfort during intimate activity. It is applied topically to body orifices and is compatible with latex condoms.

  • Is O'My Natural Lubricant sterile?

    No, O'My Natural Lubricant is non-sterile. It is classified as a personal lubricant with product code NUC and is intended for consumer use in home settings.

  • What sizes are available for O'My Natural Lubricant?

    O'My Natural Lubricant is available in multiple sizes as indicated by the various registration numbers provided. The specific size options are not detailed in the available information.

  • Does O'My Natural Lubricant contain electronic or mechanical components?

    No, O'My Natural Lubricant functions solely as a physical lubricant with no active electronic or mechanical components. It is a water-based product designed to reduce friction during intimate activity.