FDA 510(k)

粉体不使用ニトリル患者検査手袋、非無菌（青色）

K番号: K210755 · 2021-05-07

決定日2021-05-07

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

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Meditech Gloves Sdn Bhd. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K210755. 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 Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)?

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Meditech Gloves Sdn Bhd. The 510(k) number is K210755.

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

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) received FDA 510(k) clearance on 2021-05-07, under 510(k) number K210755.

Who is the listed applicant for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)?

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

What is the FDA product code for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)?

The FDA product code for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) is LZA.

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

K213408BPG ChemoPlus ニトリル患者検査手袋、粉体不使用

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