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FDA 510(k)

DUREX LATEX CONDOMS

K-Number: K980204 · 1998-04-17

ApplicantLondon Intl., LLC
Decision Date1998-04-17
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DUREX LATEX CONDOMS is the device name listed in this FDA 510(k) record. The listed applicant is London Intl., LLC. It received FDA 510(k) clearance on 1998-04-17 under 510(k) number K980204. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUREX LATEX CONDOMS?

DUREX LATEX CONDOMS is a medical device that received FDA 510(k) clearance on 1998-04-17. The listed applicant is London Intl., LLC. The 510(k) number is K980204.

When did DUREX LATEX CONDOMS receive FDA 510(k) clearance?

DUREX LATEX CONDOMS received FDA 510(k) clearance on 1998-04-17, under 510(k) number K980204.

Who is the listed applicant for DUREX LATEX CONDOMS?

The FDA 510(k) record lists London Intl., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUREX LATEX CONDOMS?

The FDA product code for DUREX LATEX CONDOMS is HIS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing London Intl., LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K982924DUREX SENSIDOM LATEX CONDOMK983380DUREX LUBRAGEL LATEX CONDOMK980174DUREX COLORS AND SCENTSK980785STERILE, POWDERFREE LATEX EXAMINATION GLOVEK980319DUREX ULTRA COMFORT

Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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