FDA 510(k)

Nitrile Examination Gloves

N.º K: K213739 · 2022-06-22

SolicitanteHangzhou Runheng Medical Co., Ltd.

Fecha de decisión2022-06-22

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Runheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K213739. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Nitrile Examination Gloves?

Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Hangzhou Runheng Medical Co., Ltd.. The 510(k) number is K213739.

When did Nitrile Examination Gloves receive FDA 510(k) clearance?

Nitrile Examination Gloves received FDA 510(k) clearance on 2022-06-22, under 510(k) number K213739.

Who is the listed applicant for Nitrile Examination Gloves?

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

What is the FDA product code for Nitrile Examination Gloves?

The FDA product code for Nitrile Examination Gloves is LZA.

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Otros registros que enlistan a Hangzhou Runheng Medical Co., Ltd. como solicitante

K213736Medical Face Mask

Dispositivos relacionados (Código: LZA)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.