FDA 510(k)

U-MED Powder Free Polyethylene Examination Gloves,Blue Color

N.º K: K173228 · 2018-02-20

SolicitanteJiangsu U-Med Rubber & Plastic Products Co., Ltd.

Fecha de decisión2018-02-20

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

U-MED Powder Free Polyethylene Examination Gloves,Blue Color is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu U-Med Rubber & Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2018-02-20 under 510(k) number K173228. 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 U-MED Powder Free Polyethylene Examination Gloves,Blue Color?

U-MED Powder Free Polyethylene Examination Gloves,Blue Color is a medical device that received FDA 510(k) clearance on 2018-02-20. The listed applicant is Jiangsu U-Med Rubber & Plastic Products Co., Ltd.. The 510(k) number is K173228.

When did U-MED Powder Free Polyethylene Examination Gloves,Blue Color receive FDA 510(k) clearance?

U-MED Powder Free Polyethylene Examination Gloves,Blue Color received FDA 510(k) clearance on 2018-02-20, under 510(k) number K173228.

Who is the listed applicant for U-MED Powder Free Polyethylene Examination Gloves,Blue Color?

The FDA 510(k) record lists Jiangsu U-Med Rubber & Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-MED Powder Free Polyethylene Examination Gloves,Blue Color?

The FDA product code for U-MED Powder Free Polyethylene Examination Gloves,Blue Color is LZA.

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Fuente oficial

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