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FDA 510(k)

Natural rubber latex male condom

Número K: K250034 · 2025-07-11

RequerenteShaoguan Regenex Pharmaceuticals Co., Ltd.
Data da decisão2025-07-11
Código do produtoHIS
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

Natural rubber latex male condom is the device name listed in this FDA 510(k) record. The listed applicant is Shaoguan Regenex Pharmaceuticals Co., Ltd.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K250034. 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 Natural rubber latex male condom?

Natural rubber latex male condom is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Shaoguan Regenex Pharmaceuticals Co., Ltd.. The 510(k) number is K250034.

When did Natural rubber latex male condom receive FDA 510(k) clearance?

Natural rubber latex male condom received FDA 510(k) clearance on 2025-07-11, under 510(k) number K250034.

Who is the listed applicant for Natural rubber latex male condom?

The FDA 510(k) record lists Shaoguan Regenex Pharmaceuticals Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Natural rubber latex male condom?

The FDA product code for Natural rubber latex male condom is HIS.

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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 LimitedK243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.K2435840.04 ZERO ZERO QUATRO Condom de Latex MasculinoOkamoto USA, Inc.

Fonte oficial

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