FDA 510(k)

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove

Número K: K171987 · 2017-10-20

Data da decisão2017-10-20

Código do produtoKGO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Finessis Zero Flexylon Powder Free Sterile White 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 2017-10-20 under 510(k) number K171987. 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 Zero Flexylon Powder Free Sterile White Surgical Glove?

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Lucenxia Prescience AG. The 510(k) number is K171987.

When did Finessis Zero Flexylon Powder Free Sterile White Surgical Glove receive FDA 510(k) clearance?

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove received FDA 510(k) clearance on 2017-10-20, under 510(k) number K171987.

Who is the listed applicant for Finessis Zero Flexylon Powder Free Sterile White 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 Zero Flexylon Powder Free Sterile White Surgical Glove?

The FDA product code for Finessis Zero Flexylon Powder Free Sterile White Surgical Glove is KGO.

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

K173304Finessis Intense Polyisoprene Surgical Glove K173386Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs K162852Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove

Dispositivos Relacionados (Código: KGO)

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 Limited K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbH K240790Polyisoprene 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.

Fonte oficial

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