FDA 510(k)

Disposable Nitrile Medical Examination Glove

N.º K: K211131 · 2021-07-29

SolicitanteSiyang Threeguard Medical Supplies Co., Ltd.

Fecha de decisión2021-07-29

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Nitrile Medical Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Siyang Threeguard Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K211131. 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 Disposable Nitrile Medical Examination Glove?

Disposable Nitrile Medical Examination Glove is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Siyang Threeguard Medical Supplies Co., Ltd.. The 510(k) number is K211131.

When did Disposable Nitrile Medical Examination Glove receive FDA 510(k) clearance?

Disposable Nitrile Medical Examination Glove received FDA 510(k) clearance on 2021-07-29, under 510(k) number K211131.

Who is the listed applicant for Disposable Nitrile Medical Examination Glove?

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

What is the FDA product code for Disposable Nitrile Medical Examination Glove?

The FDA product code for Disposable Nitrile Medical Examination Glove 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.

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 Siyang Threeguard Medical Supplies Co., Ltd. como solicitante

K212834Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)

Dispositivos relacionados (Código: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* 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.