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FDA 510(k)

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

N.º K: K200181 · 2020-04-15

SolicitanteComfort Rubber Gloves Industries Sdn. Bhd.
Fecha de decisión2020-04-15
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2020-04-15 under 510(k) number K200181. 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 Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2020-04-15. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K200181.

When did Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate receive FDA 510(k) clearance?

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2020-04-15, under 510(k) number K200181.

Who is the listed applicant for Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA 510(k) record lists Comfort Rubber Gloves Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is LZA.

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Otros registros que enlistan a Comfort Rubber Gloves Industries 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.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinK240269Nitrile Powder Free Examination Gloves Biodegradable (Green)K241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis PotentialK192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylK190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)K180476Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

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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

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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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