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Durex Spearmint Scented Lubricated Latex Condom

by Ssl Americas, Inc.

510(k) K042470

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 · Abbreviated NumberK042470 Date5 Apr 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  • Withdrawn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)

Full name
Durex Spearmint Scented Lubricated Latex Condom (Durex 'tingling Pleasure' Condom
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

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Durex Spearmint Scented Lubricated Latex Condom is a shaped, teat-ended, transparent condom made of natural rubber latex. It is lubricated with a spearmint scented lubricant and designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492.

This device is supplied as a single-use product and is not MRI safe. It is a Class II medical device cleared by the FDA under 510(k) K042470 for use as a contraceptive and to help reduce the risk of transmission of sexually transmitted infections. The device is manufactured by SSL Americas, Inc. and is regulated under product code HIS.

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Questions

AI-generated answers, 6 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 Durex Spearmint Scented Lubricated Latex Condom used for?

    The Durex Spearmint Scented Lubricated Latex Condom is designed for use as a contraceptive and to help reduce the risk of transmission of sexually transmitted infections. It is a Class II medical device that conforms to national and international voluntary standards.

  • Is the Durex Spearmint Scented Condom reusable or single-use?

    This device is supplied as a single-use product and should not be reused. It is designed for one-time use only to ensure proper protection and hygiene.

  • What are the specifications of the Durex Spearmint Scented Condom?

    The Durex Spearmint Scented Lubricated Latex Condom is a shaped, teat-ended, transparent condom made of natural rubber latex. It is lubricated with a spearmint scented lubricant and designed to conform to ISO 4074:2002 and ASTM D3492 standards.

  • Is the Durex Spearmint Scented Condom MRI safe?

    No, the Durex Spearmint Scented Lubricated Latex Condom is not MRI safe. It should not be used in MRI environments as it may not maintain its integrity under those conditions.