FDA 510(k)

Disposable Surgical Gown

N.º K: K212925 · 2021-12-13

SolicitanteHenan Robestain Medical Products Co., Ltd.

Fecha de decisión2021-12-13

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Henan Robestain Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K212925. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Surgical Gown?

Disposable Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Henan Robestain Medical Products Co., Ltd.. The 510(k) number is K212925.

When did Disposable Surgical Gown receive FDA 510(k) clearance?

Disposable Surgical Gown received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212925.

Who is the listed applicant for Disposable Surgical Gown?

The FDA 510(k) record lists Henan Robestain Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Gown?

The FDA product code for Disposable Surgical Gown is FYA.

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Fuente oficial

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