FDA 510(k)

ニトリル使い捨て検査手袋

K番号: K212578 · 2021-12-02

決定日2021-12-02

製品コードLZA

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

Nitrile disposable examination gloves is the device name listed in this FDA 510(k) record. The listed applicant is Xingyu Medical Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K212578. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Nitrile disposable examination gloves?

Nitrile disposable examination gloves is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Xingyu Medical Tech Co., Ltd.. The 510(k) number is K212578.

When did Nitrile disposable examination gloves receive FDA 510(k) clearance?

Nitrile disposable examination gloves received FDA 510(k) clearance on 2021-12-02, under 510(k) number K212578.

Who is the listed applicant for Nitrile disposable examination gloves?

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

What is the FDA product code for Nitrile disposable examination gloves?

The FDA product code for Nitrile disposable examination gloves is LZA.

申請者としてXingyu Medical Tech Co., Ltd.を記載するその他の記録

K240629ニトリル使い捨て検査手袋、化学療法薬およびフェンタニルとの使用試験済 K221273医療用フェースマスク（M001）K212735ニトリル使い捨て検査手袋（化学療法薬との使用試験済み）

公式ソース

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