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FDA 510(k)

Lifestyles Zero Lubricated Latex Male Condom

Número K: K163107 · 2017-01-23

RequerenteAnsell Healthcare Products, LLC
Data da decisão2017-01-23
Código do produtoHIS
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

Lifestyles Zero Lubricated Latex Male Condom is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2017-01-23 under 510(k) number K163107. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lifestyles Zero Lubricated Latex Male Condom?

Lifestyles Zero Lubricated Latex Male Condom is a medical device that received FDA 510(k) clearance on 2017-01-23. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K163107.

When did Lifestyles Zero Lubricated Latex Male Condom receive FDA 510(k) clearance?

Lifestyles Zero Lubricated Latex Male Condom received FDA 510(k) clearance on 2017-01-23, under 510(k) number K163107.

Who is the listed applicant for Lifestyles Zero Lubricated Latex Male Condom?

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

What is the FDA product code for Lifestyles Zero Lubricated Latex Male Condom?

The FDA product code for Lifestyles Zero Lubricated Latex Male Condom is HIS.

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Ver todos os 14 dispositivos →

Dispositivos Relacionados (Código: HIS)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.

Fonte oficial

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