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FDA 510(k)

ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM

K-Number: K082529 · 2009-05-01

ApplicantAlatech Healthcare, LLC
Decision Date2009-05-01
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Alatech Healthcare, LLC. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K082529. 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 ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM?

ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is Alatech Healthcare, LLC. The 510(k) number is K082529.

When did ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM receive FDA 510(k) clearance?

ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM received FDA 510(k) clearance on 2009-05-01, under 510(k) number K082529.

Who is the listed applicant for ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM?

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

What is the FDA product code for ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM?

The FDA product code for ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM is HIS.

Related Clinical Trials

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Other records listing Alatech Healthcare, 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.

K083761ALATECH POWDER FREE LATEX EXAMINATION GLOVEK080606ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVEK993887ALATECH 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

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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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