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Naturdom Condom

by Juan C. Lucena 510(k)

Active United States

510(k) K790433

Overview

The Naturdom Condom is a barrier contraceptive device designed to prevent pregnancy and sexually transmitted infections during vaginal intercourse. Classified as a condom under the FDA’s nomenclature, it is intended for single-use protection during sexual activity, providing a physical barrier between partners to reduce the risk of unintended conception and infection transmission.

Supplied as a sterile, single-use product, the Naturdom Condom is intended for use in clinical and consumer settings. It is regulated under FDA’s 510(k) clearance (K790433) and falls under the Obstetrics/Gynecology advisory committee classification. The device is non-reusable and must be stored in a cool, dry place away from direct sunlight to maintain integrity. No MRI safety considerations apply, as it is not a medical imaging-related product.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790433 Date4 Oct 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Naturdom
510(k) Number
FDA Product Code
HIS
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Naturdom Condom used for?

    The Naturdom Condom is a barrier contraceptive designed to prevent pregnancy and sexually transmitted infections (STIs) during vaginal intercourse. It acts as a physical barrier between partners, reducing the risk of unintended conception and infection transmission.

  • Is the Naturdom Condom sterile and single-use?

    Yes, the Naturdom Condom is supplied as a sterile, single-use product. This ensures safety and hygiene for each use, preventing cross-contamination between multiple applications.

  • How should the Naturdom Condom be stored?

    The Naturdom Condom must be stored in a cool, dry place away from direct sunlight to maintain its integrity. Proper storage conditions help preserve its effectiveness and prevent degradation.

  • Can the Naturdom Condom be reused?

    No, the Naturdom Condom is explicitly designed for single-use only. Reusing it compromises its barrier properties and increases the risk of failure in preventing pregnancy or STIs.

  • What regulatory clearance does the Naturdom Condom have?

    The Naturdom Condom holds FDA 510(k) clearance under the classification K790433, with a decision of ‘Substantially Equivalent’ under the Obstetrics/Gynecology advisory committee. This clearance confirms its compliance with U.S. regulatory standards for barrier contraceptives.