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FDA 510(k)

DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS

K-Number: K052959 · 2006-01-27

ApplicantSsl Americas
Decision Date2006-01-27
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS is the device name listed in this FDA 510(k) record. The listed applicant is Ssl Americas. It received FDA 510(k) clearance on 2006-01-27 under 510(k) number K052959. 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 MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS?

DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS is a medical device that received FDA 510(k) clearance on 2006-01-27. The listed applicant is Ssl Americas. The 510(k) number is K052959.

When did DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS receive FDA 510(k) clearance?

DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS received FDA 510(k) clearance on 2006-01-27, under 510(k) number K052959.

Who is the listed applicant for DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS?

The FDA 510(k) record lists Ssl Americas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS?

The FDA product code for DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS is HIS.

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Other records listing Ssl Americas 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.

K072236DUREX PLAY TINGLING AQUEOUS BASED LUBRICANTK071626DUREX PLAY SOFT & SENSUAL LUBRICANTK042957DUREX MALE LATEX CONDOM WITH WARMING LUBRICANTK040185DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM

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

View on FDA Database →

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

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