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FDA 510(k)

Sterile Latex Surgical Glove, Powder Free

N.º K: K190241 · 2019-12-30

SolicitanteCareglove Global Sdn. Bhd.
Fecha de decisión2019-12-30
Código de productoKGO
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Latex Surgical Glove, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2019-12-30 under 510(k) number K190241. 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 Latex Surgical Glove, Powder Free?

Sterile Latex Surgical Glove, Powder Free is a medical device that received FDA 510(k) clearance on 2019-12-30. The listed applicant is Careglove Global Sdn. Bhd.. The 510(k) number is K190241.

When did Sterile Latex Surgical Glove, Powder Free receive FDA 510(k) clearance?

Sterile Latex Surgical Glove, Powder Free received FDA 510(k) clearance on 2019-12-30, under 510(k) number K190241.

Who is the listed applicant for Sterile Latex Surgical Glove, Powder Free?

The FDA 510(k) record lists Careglove Global Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Latex Surgical Glove, Powder Free?

The FDA product code for Sterile Latex Surgical Glove, Powder Free is KGO.

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Otros registros que enlistan a Careglove Global Sdn. Bhd. como solicitante

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K250578Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)K230121Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)K220859Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)K213993Powder Free Chloroprene Examination Glove Coloured (Blue, Green)K211666Powder Free Nitrile Examination Gloves, Blue ChemotestK172015POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)

Ver todos los 8 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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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