Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs

N.º K: K163146 · 2017-02-13

SolicitanteHebei Hongsen Plastics Technology Co, Ltd.
Fecha de decisión2017-02-13
Código de productoLZC
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Hongsen Plastics Technology Co, Ltd.. It received FDA 510(k) clearance on 2017-02-13 under 510(k) number K163146. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Hebei Hongsen Plastics Technology Co, Ltd.. The 510(k) number is K163146.

When did POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-02-13, under 510(k) number K163146.

Who is the listed applicant for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

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

What is the FDA product code for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

The FDA product code for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is LZC.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: LZC)

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.

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn BhdK220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

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.

↑