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FDA 510(k)

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim

N.º K: K180452 · 2018-06-12

SolicitanteRiverstone Resources Sdn Bhd
Fecha de decisión2018-06-12
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim is the device name listed in this FDA 510(k) record. The listed applicant is Riverstone Resources Sdn Bhd. It received FDA 510(k) clearance on 2018-06-12 under 510(k) number K180452. 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 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim?

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is Riverstone Resources Sdn Bhd. The 510(k) number is K180452.

When did White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim receive FDA 510(k) clearance?

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim received FDA 510(k) clearance on 2018-06-12, under 510(k) number K180452.

Who is the listed applicant for White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim?

The FDA 510(k) record lists Riverstone Resources Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim?

The FDA product code for White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim is LZA.

Ensayos clínicos relacionados

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Otros registros que enlistan a Riverstone Resources Sdn Bhd 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.

K220672Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test ClaimK220401Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test ClaimK200326Powder Free Nitrile Examination Glove (Aqua Green)K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

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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