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FDA 510(k)

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove

N.º K: K201592 · 2021-09-26

SolicitanteCardinal Health200, LLC
Fecha de decisión2021-09-26
Código de productoKGO
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2021-09-26 under 510(k) number K201592. 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 Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is a medical device that received FDA 510(k) clearance on 2021-09-26. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K201592.

When did Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove receive FDA 510(k) clearance?

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove received FDA 510(k) clearance on 2021-09-26, under 510(k) number K201592.

Who is the listed applicant for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove?

The FDA product code for Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove is KGO.

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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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