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FDA 510(k)

mCare(R) Powder Free Nitrile Orange Examination Gloves

N.º K: K200967 · 2020-06-06

SolicitanteMercator Medical (Thailand), Ltd.
Fecha de decisión2020-06-06
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

mCare(R) Powder Free Nitrile Orange Examination Gloves 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 2020-06-06 under 510(k) number K200967. 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 mCare(R) Powder Free Nitrile Orange Examination Gloves?

mCare(R) Powder Free Nitrile Orange Examination Gloves is a medical device that received FDA 510(k) clearance on 2020-06-06. The listed applicant is Mercator Medical (Thailand), Ltd.. The 510(k) number is K200967.

When did mCare(R) Powder Free Nitrile Orange Examination Gloves receive FDA 510(k) clearance?

mCare(R) Powder Free Nitrile Orange Examination Gloves received FDA 510(k) clearance on 2020-06-06, under 510(k) number K200967.

Who is the listed applicant for mCare(R) Powder Free Nitrile Orange Examination Gloves?

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 mCare(R) Powder Free Nitrile Orange Examination Gloves?

The FDA product code for mCare(R) Powder Free Nitrile Orange Examination Gloves is LZA.

Ensayos clínicos relacionados

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Otros registros que enlistan a Mercator Medical (Thailand), Ltd. 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.

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 CitrateK213548Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with ChemotherapyK192444mCare® Powder Free Nitrile Black Examination GloveK190876mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling ClaimedK172930mCare Powder-free Blue Nitrile Examination Gloves

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.

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