Fecha de decisión2023-05-23
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent
Resumen del dispositivo
Green Non Sterile Powder Free Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Central Medicare Sdn Bhd. It received FDA 510(k) clearance on 2023-05-23 under 510(k) number K230564. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Preguntas frecuentes
What is the Green Non Sterile Powder Free Nitrile Examination Gloves?
Green Non Sterile Powder Free Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2023-05-23. The listed applicant is Central Medicare Sdn Bhd. The 510(k) number is K230564.
When did Green Non Sterile Powder Free Nitrile Examination Gloves receive FDA 510(k) clearance?
Green Non Sterile Powder Free Nitrile Examination Gloves received FDA 510(k) clearance on 2023-05-23, under 510(k) number K230564.
Who is the listed applicant for Green Non Sterile Powder Free Nitrile Examination Gloves?
The FDA 510(k) record lists Central Medicare Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Green Non Sterile Powder Free Nitrile Examination Gloves?
The FDA product code for Green Non Sterile Powder Free Nitrile Examination Gloves is LZA.
Ensayos clínicos relacionados
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.
Otros registros que enlistan a Central Medicare Sdn Bhd 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.
K230681Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and FentanylK223752Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and FentanylK230875Guantes de Examen de Polímero de Nitrilo No Estériles y Sin Polvo Azul Probados para el Uso con Medicamentos Químicos, con Reclamos de Resistencia a la Permeación de Ácido Gástrico y FentaniloK213437Guantes de Examen de Polímero de Nitrilo No Estériles y Sin Polvo Azul Probados para el Uso con Medicamentos Químicos, con Reclamos de Resistencia a la Permeación de Ácido Gástrico y FentaniloK211022Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.K203036Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) Ver todos los 11 dispositivos →
Dispositivos relacionados (Código: LZA)
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.
K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.
Fuente oficial
Ver en la base de datos de la FDA →Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.