FDA 510(k)

Disposable Powder Free Polyethylene Examination Gloves

N.º K: K212699 · 2022-05-31

SolicitanteMastermax Plastic (Huizhou), Ltd.

Fecha de decisión2022-05-31

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Powder Free Polyethylene Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Mastermax Plastic (Huizhou), Ltd.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K212699. 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 Disposable Powder Free Polyethylene Examination Gloves?

Disposable Powder Free Polyethylene Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Mastermax Plastic (Huizhou), Ltd.. The 510(k) number is K212699.

When did Disposable Powder Free Polyethylene Examination Gloves receive FDA 510(k) clearance?

Disposable Powder Free Polyethylene Examination Gloves received FDA 510(k) clearance on 2022-05-31, under 510(k) number K212699.

Who is the listed applicant for Disposable Powder Free Polyethylene Examination Gloves?

The FDA 510(k) record lists Mastermax Plastic (Huizhou), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Powder Free Polyethylene Examination Gloves?

The FDA product code for Disposable Powder Free Polyethylene Examination Gloves is LZA.

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Fuente oficial

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