FDA 510(k)

Vinyl Exam Gloves, Powder Free, Clear

Número K: K161390 · 2016-12-19

RequerenteZibo Hongchin Plastic and Rubber Co., Ltd.

Data da decisão2016-12-19

Código do produtoLYZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vinyl Exam Gloves, Powder Free, Clear is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Hongchin Plastic and Rubber Co., Ltd.. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K161390. 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 Exam Gloves, Powder Free, Clear?

Vinyl Exam Gloves, Powder Free, Clear is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Zibo Hongchin Plastic and Rubber Co., Ltd.. The 510(k) number is K161390.

When did Vinyl Exam Gloves, Powder Free, Clear receive FDA 510(k) clearance?

Vinyl Exam Gloves, Powder Free, Clear received FDA 510(k) clearance on 2016-12-19, under 510(k) number K161390.

Who is the listed applicant for Vinyl Exam Gloves, Powder Free, Clear?

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

What is the FDA product code for Vinyl Exam Gloves, Powder Free, Clear?

The FDA product code for Vinyl Exam Gloves, Powder Free, Clear is LYZ.

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Fonte oficial

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