FDA 510(k)

抗がん剤薬との使用を試験された非ステリル無粉ニトリル検査手袋

K番号: K172864 · 2018-05-02

決定日2018-05-02

製品コードLZC

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

Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Maxter Glove Manufacturing Sdn Bhd. It received FDA 510(k) clearance on 2018-05-02 under 510(k) number K172864. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-05-02. The listed applicant is Maxter Glove Manufacturing Sdn Bhd. The 510(k) number is K172864.

When did Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-05-02, under 510(k) number K172864.

Who is the listed applicant for Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Maxter Glove Manufacturing Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA product code for Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is LZC.

申請者としてMaxter Glove Manufacturing Sdn Bhdを記載するその他の記録

K151390粉体不使用ニトリル検査手袋（化学療法薬との使用試験済み）

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