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FDA 510(k)

Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)

N.º K: K200960 · 2020-07-13

SolicitanteMedline Industires, Inc.
Fecha de decisión2020-07-13
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industires, Inc.. It received FDA 510(k) clearance on 2020-07-13 under 510(k) number K200960. 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 Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)?

Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2020-07-13. The listed applicant is Medline Industires, Inc.. The 510(k) number is K200960.

When did Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) received FDA 510(k) clearance on 2020-07-13, under 510(k) number K200960.

Who is the listed applicant for Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)?

The FDA 510(k) record lists Medline Industires, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)?

The FDA product code for Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) is LZA.

Ensayos clínicos relacionados

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Otros registros que enlistan a Medline Industires, Inc. 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.

K220955Hudson RCI Variable concentration Large Volume Nebulizer (1770)K201129Medline Smoke Evacuation PencilK201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)K201319Medline UNITE Jones Fracture Screw System

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

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