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Natural Ordinary Ribbed, Dotted, and Contoured (Male Rubber Latex Condom, Lubricated W/Silicone Oil

by Dongkuk Techco Rubber Industries

510(k) K002060

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 NumberK002060 Date7 Sep 2000ClearedStatusActive

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  • Withdrawn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
HIS
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

This device is a male rubber latex condom featuring a ribbed, dotted, and contoured surface design, supplied lubricated with silicone oil. It is classified as a condom under medical device regulations and falls within the obstetrics/gynecology specialty. The product is intended for use as a barrier method of contraception and for helping to reduce the risk of unintended pregnancy and certain sexually transmitted infections.

The device is manufactured by Dongkuk Techco Rubber Industries and is regulated under product code HIS, with a classification under regulation number 884.5300. It is a single-use, disposable device supplied in sterile packaging and is not intended for reuse. The device is not evaluated for MRI compatibility, and storage conditions should follow manufacturer guidelines. The device received a substantially equivalent determination under an Abbreviated 510(k) review process.

Other devices from Dongkuk Techco Rubber Industries

Questions

AI-generated answers, 25 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 this device intended for?

    This device is a male latex condom designed as a barrier method for contraception. It helps reduce the risk of unintended pregnancy and certain sexually transmitted infections through its physical barrier properties.

  • How is the device supplied?

    The device is supplied in sterile packaging as a single-use, disposable item. It is lubricated with silicone oil and should not be reused or resterilized.

  • What surface features does the condom have?

    The condom features a ribbed, dotted, and contoured surface design. These textures are intended to enhance sensation and fit during use, while maintaining the structural integrity of the latex material.

  • Is this device compatible with MRI?

    The device has not been evaluated for MRI compatibility. It contains no metallic components, but patients should consult the manufacturer’s guidelines before undergoing magnetic resonance imaging.

  • What regulatory pathway was used for clearance?

    The device was cleared through an Abbreviated 510(k) review process, receiving a substantially equivalent determination. It is classified under product code HIS and regulation number 884.5300 in the obstetrics/gynecology specialty.