FDA 510(k)

Medline Open-back Level 3 Protective Gown

N.º K: K233526 · 2024-03-05

Fecha de decisión2024-03-05

Código de productoQPC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medline Open-back Level 3 Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-03-05 under 510(k) number K233526. 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 Medline Open-back Level 3 Protective Gown?

Medline Open-back Level 3 Protective Gown is a medical device that received FDA 510(k) clearance on 2024-03-05. The listed applicant is Medline Industries, LP. The 510(k) number is K233526.

When did Medline Open-back Level 3 Protective Gown receive FDA 510(k) clearance?

Medline Open-back Level 3 Protective Gown received FDA 510(k) clearance on 2024-03-05, under 510(k) number K233526.

Who is the listed applicant for Medline Open-back Level 3 Protective Gown?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Open-back Level 3 Protective Gown?

The FDA product code for Medline Open-back Level 3 Protective Gown is QPC.

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Otros registros que enlistan a Medline Industries, LP como solicitante

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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 K230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.K222128Protective Gown AAMI Level 4Kenpax International Limited

Fuente oficial

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