FDA 510(k)

Dukal Corporation AAMI Level 4 Open-Back Protective Gown

Número K: K212464 · 2022-03-30

Data da decisão2022-03-30

Código do produtoQPC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dukal Corporation AAMI Level 4 Open-Back Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corporation. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K212464. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

Dukal Corporation AAMI Level 4 Open-Back Protective Gown is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Dukal Corporation. The 510(k) number is K212464.

When did Dukal Corporation AAMI Level 4 Open-Back Protective Gown receive FDA 510(k) clearance?

Dukal Corporation AAMI Level 4 Open-Back Protective Gown received FDA 510(k) clearance on 2022-03-30, under 510(k) number K212464.

Who is the listed applicant for Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

The FDA 510(k) record lists Dukal Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

The FDA product code for Dukal Corporation AAMI Level 4 Open-Back Protective Gown is QPC.

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Outros registros que listam Dukal Corporation como candidato(a)

K210321Dukal Corporation Level 1 Pediatric Face Mask K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons

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.K242689Gown Protetor de Nível 4 AAMIAzac Group K233526Medline Open-back Level 3 Protective GownMedline Industries, LP K230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.

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