FDA 510(k)

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy

N.º K: K213548 · 2022-02-21

SolicitanteMercator Medical (Thailand), Ltd.

Fecha de decisión2022-02-21

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy is the device name listed in this FDA 510(k) record. The listed applicant is Mercator Medical (Thailand), Ltd.. It received FDA 510(k) clearance on 2022-02-21 under 510(k) number K213548. 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 Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy?

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy is a medical device that received FDA 510(k) clearance on 2022-02-21. The listed applicant is Mercator Medical (Thailand), Ltd.. The 510(k) number is K213548.

When did Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy receive FDA 510(k) clearance?

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy received FDA 510(k) clearance on 2022-02-21, under 510(k) number K213548.

Who is the listed applicant for Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy?

The FDA 510(k) record lists Mercator Medical (Thailand), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy?

The FDA product code for Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy 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 Mercator Medical (Thailand), Ltd. como solicitante

K251141Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K200967mCare(R) Powder Free Nitrile Orange Examination Gloves K192444mCare® Powder Free Nitrile Black Examination Glove K190876mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed K172930mCare Powder-free Blue Nitrile Examination Gloves

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.