FDA 510(k)

disposable ニトリル検査手袋（化学療法薬との使用試験済み）

K番号: K222642 · 2022-09-20

申請者Inner Mongolia Cureguard Medical Technology Co., Ltd.

決定日2022-09-20

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Substantially Equivalent

医療機器の概要

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is the device name listed in this FDA 510(k) record. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K222642. 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 Nitrile Examination Glove(Tested for use with Chemotherapy Drug)?

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Inner Mongolia Cureguard Medical Technology Co., Ltd.. The 510(k) number is K222642.

When did Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) receive FDA 510(k) clearance?

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) received FDA 510(k) clearance on 2022-09-20, under 510(k) number K222642.

Who is the listed applicant for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)?

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

What is the FDA product code for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)?

The FDA product code for Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) is LZA.

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

K212661disposable ニトリル検査手袋 K212401disposable ニトリル検査手袋

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