Fecha de decisión2021-10-31
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent
Resumen del dispositivo
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Onetexx Sdn Bhd. It received FDA 510(k) clearance on 2021-10-31 under 510(k) number K210588. 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 Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2021-10-31. The listed applicant is Onetexx Sdn Bhd. The 510(k) number is K210588.
When did Black Nitrile Powder Free Patient Examination Glove, Non Sterile receive FDA 510(k) clearance?
Black Nitrile Powder Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2021-10-31, under 510(k) number K210588.
Who is the listed applicant for Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
The FDA 510(k) record lists Onetexx Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
The FDA product code for Black Nitrile Powder Free Patient Examination Glove, Non Sterile 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 Onetexx 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.
K222298Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric AcidK222294Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric AcidK221773Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric AcidK210775White Nitrile Powder Free Patient Examination Glove, Non SterileK210587Violet Nitrile Powder Free Patient Examination Glove, Non SterileK210366Blue Nitrile Powder Free Patient Examination Glove, Non Sterile Ver todos los 7 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.