FDA 510(k)

ビニル患者検査手袋、粉無し

K番号: K153159 · 2016-01-26

決定日2016-01-26

製品コードLYZ

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

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.

よくある質問

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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ビニル患者検査手袋、粉無し

医療機器の概要

よくある質問

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関連機器（コード：LYZ）

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