FDA 510(k)

Vinyl Examination Glove (Clear, Non-Colored)

Número K: K180861 · 2018-06-13

Data da decisão2018-06-13

Código do produtoLYZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vinyl Examination Glove (Clear, Non-Colored) is the device name listed in this FDA 510(k) record. The listed applicant is Zhicheng Trading Co., Ltd.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K180861. 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 Examination Glove (Clear, Non-Colored)?

Vinyl Examination Glove (Clear, Non-Colored) is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Zhicheng Trading Co., Ltd.. The 510(k) number is K180861.

When did Vinyl Examination Glove (Clear, Non-Colored) receive FDA 510(k) clearance?

Vinyl Examination Glove (Clear, Non-Colored) received FDA 510(k) clearance on 2018-06-13, under 510(k) number K180861.

Who is the listed applicant for Vinyl Examination Glove (Clear, Non-Colored)?

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

What is the FDA product code for Vinyl Examination Glove (Clear, Non-Colored)?

The FDA product code for Vinyl Examination Glove (Clear, Non-Colored) is LYZ.

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Fonte oficial

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