FDA 510(k)

Purism Non-Sterile Powder Free Nitrile Examination Gloves

N.º K: K211319 · 2021-08-19

SolicitanteDezhou Purism Medical Technology Co., Ltd.

Fecha de decisión2021-08-19

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Purism Non-Sterile Powder Free Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Dezhou Purism Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K211319. 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 Purism Non-Sterile Powder Free Nitrile Examination Gloves?

Purism Non-Sterile Powder Free Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Dezhou Purism Medical Technology Co., Ltd.. The 510(k) number is K211319.

When did Purism Non-Sterile Powder Free Nitrile Examination Gloves receive FDA 510(k) clearance?

Purism Non-Sterile Powder Free Nitrile Examination Gloves received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211319.

Who is the listed applicant for Purism Non-Sterile Powder Free Nitrile Examination Gloves?

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

What is the FDA product code for Purism Non-Sterile Powder Free Nitrile Examination Gloves?

The FDA product code for Purism Non-Sterile Powder Free Nitrile Examination Gloves is LZA.

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Dispositivos relacionados (Código: LZA)

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Fuente oficial

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