FDA 510(k)

Medline Open-back Level 3 Protective Gown

Número K: K233526 · 2024-03-05

Data da decisão2024-03-05

Código do produtoQPC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Fonte oficial

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