FDA 510(k)

Vinyl Patient Examination Glove (Yellow)

K番号: K173561 · 2018-02-12

決定日2018-02-12

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Substantially Equivalent

医療機器の概要

Vinyl Patient Examination Glove (Yellow) is the device name listed in this FDA 510(k) record. The listed applicant is Yurun Glove Co., Ltd.. It received FDA 510(k) clearance on 2018-02-12 under 510(k) number K173561. 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 (Yellow)?

Vinyl Patient Examination Glove (Yellow) is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is Yurun Glove Co., Ltd.. The 510(k) number is K173561.

When did Vinyl Patient Examination Glove (Yellow) receive FDA 510(k) clearance?

Vinyl Patient Examination Glove (Yellow) received FDA 510(k) clearance on 2018-02-12, under 510(k) number K173561.

Who is the listed applicant for Vinyl Patient Examination Glove (Yellow)?

The FDA 510(k) record lists Yurun Glove 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 (Yellow)?

The FDA product code for Vinyl Patient Examination Glove (Yellow) is LYZ.

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Vinyl Patient Examination Glove (Yellow)

医療機器の概要

よくある質問

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