FDA 510(k)

NitriTec Vinyl Glove Powder Free Blue

N.º K: K210460 · 2021-05-17

SolicitanteZhonghong Pulin Medical Products Co., Ltd.

Fecha de decisión2021-05-17

Código de productoLYZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

NitriTec Vinyl Glove Powder Free Blue is the device name listed in this FDA 510(k) record. The listed applicant is Zhonghong Pulin Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-05-17 under 510(k) number K210460. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NitriTec Vinyl Glove Powder Free Blue?

NitriTec Vinyl Glove Powder Free Blue is a medical device that received FDA 510(k) clearance on 2021-05-17. The listed applicant is Zhonghong Pulin Medical Products Co., Ltd.. The 510(k) number is K210460.

When did NitriTec Vinyl Glove Powder Free Blue receive FDA 510(k) clearance?

NitriTec Vinyl Glove Powder Free Blue received FDA 510(k) clearance on 2021-05-17, under 510(k) number K210460.

Who is the listed applicant for NitriTec Vinyl Glove Powder Free Blue?

The FDA 510(k) record lists Zhonghong Pulin Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NitriTec Vinyl Glove Powder Free Blue?

The FDA product code for NitriTec Vinyl Glove Powder Free Blue is LYZ.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Zhonghong Pulin Medical Products Co., Ltd. como solicitante

K231029Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl K230662Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs K171873Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs K152712Nitrile Powder Free Patient Examination Gloves, Blue Color

Dispositivos relacionados (Código: LYZ)

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

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.