FDA 510(k)

Finessis Intense Polyisoprene Surgical Glove

Número K: K173304 · 2018-04-30

Data da decisão2018-04-30

Código do produtoKGO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Finessis Intense Polyisoprene Surgical Glove is the device name listed in this FDA 510(k) record. The listed applicant is Lucenxia Prescience AG. It received FDA 510(k) clearance on 2018-04-30 under 510(k) number K173304. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Finessis Intense Polyisoprene Surgical Glove?

Finessis Intense Polyisoprene Surgical Glove is a medical device that received FDA 510(k) clearance on 2018-04-30. The listed applicant is Lucenxia Prescience AG. The 510(k) number is K173304.

When did Finessis Intense Polyisoprene Surgical Glove receive FDA 510(k) clearance?

Finessis Intense Polyisoprene Surgical Glove received FDA 510(k) clearance on 2018-04-30, under 510(k) number K173304.

Who is the listed applicant for Finessis Intense Polyisoprene Surgical Glove?

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

What is the FDA product code for Finessis Intense Polyisoprene Surgical Glove?

The FDA product code for Finessis Intense Polyisoprene Surgical Glove is KGO.

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Outros registros que listam Lucenxia Prescience AG como candidato(a)

K173386Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs K171987Finessis Zero Flexylon Powder Free Sterile White Surgical Glove K162852Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove

Dispositivos Relacionados (Código: KGO)

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Fonte oficial

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