FDA 510(k)

ニトリル粉無し検査手袋、非無菌 - 青色、黑色、橙色

K番号: K220232 · 2022-02-20

決定日2022-02-20

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]

決定大幅同等

医療機器の概要

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is the device name listed in this FDA 510(k) record. The listed applicant is Megine Industries Sdn Bhd. It received FDA 510(k) clearance on 2022-02-20 under 510(k) number K220232. 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 Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange?

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is a medical device that received FDA 510(k) clearance on 2022-02-20. The listed applicant is Megine Industries Sdn Bhd. The 510(k) number is K220232.

When did Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange received FDA 510(k) clearance on 2022-02-20, under 510(k) number K220232.

Who is the listed applicant for Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange?

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

What is the FDA product code for Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange?

The FDA product code for Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange is LZA.

申請者としてMegine Industries Sdn Bhdを記載するその他の記録

K211310AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

公式ソース

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