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FDA 510(k)

Sterile Nitrile Surgical Gloves, Powder-free

N.º K: K170515 · 2017-06-09

SolicitantePrimus Gloves Pvt Limited
Fecha de decisión2017-06-09
Código de productoKGO
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Nitrile Surgical Gloves, Powder-free is the device name listed in this FDA 510(k) record. The listed applicant is Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K170515. 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 Nitrile Surgical Gloves, Powder-free?

Sterile Nitrile Surgical Gloves, Powder-free is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Primus Gloves Pvt Limited. The 510(k) number is K170515.

When did Sterile Nitrile Surgical Gloves, Powder-free receive FDA 510(k) clearance?

Sterile Nitrile Surgical Gloves, Powder-free received FDA 510(k) clearance on 2017-06-09, under 510(k) number K170515.

Who is the listed applicant for Sterile Nitrile Surgical Gloves, Powder-free?

The FDA 510(k) record lists Primus Gloves Pvt Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Nitrile Surgical Gloves, Powder-free?

The FDA product code for Sterile Nitrile Surgical Gloves, Powder-free is KGO.

Ensayos clínicos relacionados

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Otros registros que enlistan a Primus Gloves Pvt Limited 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.

K170612STERILE VINYL EXAMINATION GLOVES, Powder FreeK143477Nitrile Patient Examination gloves, Powderfree, Blue color

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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