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FDA 510(k)

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs

N.º K: K173386 · 2018-04-09

SolicitanteLucenxia Prescience AG
Fecha de decisión2018-04-09
Código de productoKGO
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs 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 2018-04-09 under 510(k) number K173386. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs?

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-04-09. The listed applicant is Lucenxia Prescience AG. The 510(k) number is K173386.

When did Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs receive FDA 510(k) clearance?

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-04-09, under 510(k) number K173386.

Who is the listed applicant for Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs?

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 Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs?

The FDA product code for Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs is KGO.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Otros registros que enlistan a Lucenxia Prescience AG como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K173304Finessis Intense Polyisoprene Surgical GloveK171987Finessis Zero Flexylon Powder Free Sterile White Surgical GloveK162852Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove

Dispositivos relacionados (Código: KGO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Fuente oficial

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