FDA 510(k)

Cardinal HealthTM Poly-Coated Open-Back Protective Gown

N.º K: K182830 · 2019-04-26

Fecha de decisión2019-04-26

Código de productoQPC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2019-04-26 under 510(k) number K182830. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K182830.

When did Cardinal HealthTM Poly-Coated Open-Back Protective Gown receive FDA 510(k) clearance?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown received FDA 510(k) clearance on 2019-04-26, under 510(k) number K182830.

Who is the listed applicant for Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

The FDA product code for Cardinal HealthTM Poly-Coated Open-Back Protective Gown is QPC.

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Otros registros que enlistan a Cardinal Health200, LLC como solicitante

K241780Cardinal Health Nitrile Exam Gloves K230838Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)K230028Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly K201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove K211390Nitrile Blue Powder-free Examination Glove

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Dispositivos relacionados (Código: QPC)

K262007PRIMED AAMI Level 3 Open Back GownsPRIMED Medical Products, Inc.K261115VR® Personal Protective Level 4 Gown (VR Gowns)PolyConversions, Inc.K252940VR® Personal Protective Level 3 Gown (VR Gowns)PolyConversions, Inc.K242689Gorro de Protección Nivel 4 AAMI; CamisaAzac Group K233526Medline Open-back Level 3 Protective GownMedline Industries, LP K230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.

Fuente oficial

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