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FDA 510(k)

Vinyl patient examination glove, Powder Free

Número K: K153159 · 2016-01-26

RequerenteXingyuan Plastic Products Co., Ltd.
Data da decisão2016-01-26
Código do produtoLYZ
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Vinyl patient examination glove, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Xingyuan Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2016-01-26 under 510(k) number K153159. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vinyl patient examination glove, Powder Free?

Vinyl patient examination glove, Powder Free is a medical device that received FDA 510(k) clearance on 2016-01-26. The listed applicant is Xingyuan Plastic Products Co., Ltd.. The 510(k) number is K153159.

When did Vinyl patient examination glove, Powder Free receive FDA 510(k) clearance?

Vinyl patient examination glove, Powder Free received FDA 510(k) clearance on 2016-01-26, under 510(k) number K153159.

Who is the listed applicant for Vinyl patient examination glove, Powder Free?

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

What is the FDA product code for Vinyl patient examination glove, Powder Free?

The FDA product code for Vinyl patient examination glove, Powder Free is LYZ.

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