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FDA 510(k)

Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)

N.º K: K210944 · 2021-04-29

SolicitanteHarbour Health, LLC
Fecha de decisión2021-04-29
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Harbour Health, LLC. It received FDA 510(k) clearance on 2021-04-29 under 510(k) number K210944. 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 Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)?

Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) is a medical device that received FDA 510(k) clearance on 2021-04-29. The listed applicant is Harbour Health, LLC. The 510(k) number is K210944.

When did Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) received FDA 510(k) clearance on 2021-04-29, under 510(k) number K210944.

Who is the listed applicant for Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)?

The FDA 510(k) record lists Harbour Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)?

The FDA product code for Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) is LZA.

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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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