FDA 510(k)

Chemotherapy Gloves

N.º K: K230847 · 2023-09-29

Fecha de decisión2023-09-29

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Chemotherapy Gloves is the device name listed in this FDA 510(k) record. The listed applicant is 3A Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K230847. 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 Chemotherapy Gloves?

Chemotherapy Gloves is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is 3A Glove Sdn. Bhd.. The 510(k) number is K230847.

When did Chemotherapy Gloves receive FDA 510(k) clearance?

Chemotherapy Gloves received FDA 510(k) clearance on 2023-09-29, under 510(k) number K230847.

Who is the listed applicant for Chemotherapy Gloves?

The FDA 510(k) record lists 3A Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chemotherapy Gloves?

The FDA product code for Chemotherapy Gloves is LZA.

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Otros registros que enlistan a 3A Glove Sdn. Bhd. como solicitante

K230777Patient Examination Gloves

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

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.