FDA 510(k)

disposable 医療用シンセティックニトリル検査手袋

K番号: K220354 · 2022-03-24

決定日2022-03-24

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

Disposable Medical Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Niujian Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K220354. 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 Disposable Medical Synthetic Nitrile Examination Gloves?

Disposable Medical Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Niujian Technology Co., Ltd.. The 510(k) number is K220354.

When did Disposable Medical Synthetic Nitrile Examination Gloves receive FDA 510(k) clearance?

Disposable Medical Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2022-03-24, under 510(k) number K220354.

Who is the listed applicant for Disposable Medical Synthetic Nitrile Examination Gloves?

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

What is the FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves?

The FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves is LZA.

申請者としてNiujian Technology Co., Ltd.を記載するその他の記録

K220353廃棄医療用ニトリル検査手袋－化学療法薬との使用試験済 K210706ニトリル検査手袋

公式ソース

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