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FDA 510(k)

Sterile Polyisoprene Powder Free Surgical Gloves

N.º K: K171047 · 2017-06-22

SolicitanteBetter Care Plastic Technology Co., Ltd.
Fecha de decisión2017-06-22
Código de productoKGO
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Polyisoprene Powder Free Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Better Care Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K171047. 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 Sterile Polyisoprene Powder Free Surgical Gloves?

Sterile Polyisoprene Powder Free Surgical Gloves is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Better Care Plastic Technology Co., Ltd.. The 510(k) number is K171047.

When did Sterile Polyisoprene Powder Free Surgical Gloves receive FDA 510(k) clearance?

Sterile Polyisoprene Powder Free Surgical Gloves received FDA 510(k) clearance on 2017-06-22, under 510(k) number K171047.

Who is the listed applicant for Sterile Polyisoprene Powder Free Surgical Gloves?

The FDA 510(k) record lists Better Care Plastic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Polyisoprene Powder Free Surgical Gloves?

The FDA product code for Sterile Polyisoprene Powder Free Surgical Gloves is KGO.

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Otros registros que enlistan a Better Care Plastic Technology Co., Ltd. como solicitante

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K242533Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK232266Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK232070Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)K231567Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)K223713Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)

Ver todos los 10 dispositivos →

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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