FDA 510(k)

BPG ChemoPlus ニトリル患者検査手袋、粉体不使用

K番号: K213408 · 2022-04-17

決定日2022-04-17

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

BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free 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 2022-04-17 under 510(k) number K213408. 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 BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free?

BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free is a medical device that received FDA 510(k) clearance on 2022-04-17. The listed applicant is Meditech Gloves Sdn Bhd. The 510(k) number is K213408.

When did BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free receive FDA 510(k) clearance?

BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free received FDA 510(k) clearance on 2022-04-17, under 510(k) number K213408.

Who is the listed applicant for BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free?

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 BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free?

The FDA product code for BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free is LZA.

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

K210755粉体不使用ニトリル患者検査手袋、非無菌（青色）

公式ソース

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