FDA 510(k)

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate

N.º K: K222181 · 2023-01-11

Fecha de decisión2023-01-11

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Iconic Medicare Sdn Bhd. It received FDA 510(k) clearance on 2023-01-11 under 510(k) number K222181. 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 Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2023-01-11. The listed applicant is Iconic Medicare Sdn Bhd. The 510(k) number is K222181.

When did Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate receive FDA 510(k) clearance?

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate received FDA 510(k) clearance on 2023-01-11, under 510(k) number K222181.

Who is the listed applicant for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

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

What is the FDA product code for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

The FDA product code for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is LZA.

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Otros registros que enlistan a Iconic Medicare Sdn Bhd como solicitante

K221648Iconic Latex Glove K212182Iconic Nitrile Glove

Dispositivos relacionados (Código: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Fuente oficial

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