FDA 510(k)

Vinyl Examination Gloves(Yellow)

K番号: K203666 · 2021-03-12

決定日2021-03-12

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]

決定大幅同等

医療機器の概要

Vinyl Examination Gloves(Yellow) is the device name listed in this FDA 510(k) record. The listed applicant is Lutai Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-12 under 510(k) number K203666. 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 Examination Gloves(Yellow)?

Vinyl Examination Gloves(Yellow) is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is Lutai Medical Technology Co., Ltd.. The 510(k) number is K203666.

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

Vinyl Examination Gloves(Yellow) received FDA 510(k) clearance on 2021-03-12, under 510(k) number K203666.

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

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

What is the FDA product code for Vinyl Examination Gloves(Yellow)?

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

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Vinyl Examination Gloves(Yellow)

医療機器の概要

よくある質問

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