FDA 510(k)

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

N.º K: K222898 · 2022-11-07

Fecha de decisión2022-11-07

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Safesource Direct, LLC. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K222898. 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 SafeSource Direct Blue Powder-Free Nitrile Exam Gloves?

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Safesource Direct, LLC. The 510(k) number is K222898.

When did SafeSource Direct Blue Powder-Free Nitrile Exam Gloves receive FDA 510(k) clearance?

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves received FDA 510(k) clearance on 2022-11-07, under 510(k) number K222898.

Who is the listed applicant for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves?

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

What is the FDA product code for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves?

The FDA product code for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves is LZA.

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Otros registros que enlistan a Safesource Direct, LLC como solicitante

K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)K221134Procedure Mask with Ear Loops and Surgical Mask with Ties

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.K262542Guante de examen de polvo libre de nitrilo biodegradable, verde; Guante de examen de nitrilo biodegradable sin polvo, azul púrpura probado para uso con 32 medicamentos de quimioterapia, fentanilo y resistencia a la permeación del ácido gástrico.Top 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 Guantes de Examen de Nitrilo Azul Probados para Uso con Medicamentos de Quimioterapia y Citrato de FentaniloCardinalhealth 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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