FDA 510(k)

パウダーフリー・ホワイト、ブラック、および紫のニトリル検査手袋

K番号: K231439 · 2023-08-11

決定日2023-08-11

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 White, Black, and Purple Nitrile Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is S&S Glove Corporation. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K231439. 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 White, Black, and Purple Nitrile Examination Glove?

Powder Free White, Black, and Purple Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is S&S Glove Corporation. The 510(k) number is K231439.

When did Powder Free White, Black, and Purple Nitrile Examination Glove receive FDA 510(k) clearance?

Powder Free White, Black, and Purple Nitrile Examination Glove received FDA 510(k) clearance on 2023-08-11, under 510(k) number K231439.

Who is the listed applicant for Powder Free White, Black, and Purple Nitrile Examination Glove?

The FDA 510(k) record lists S&S Glove Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free White, Black, and Purple Nitrile Examination Glove?

The FDA product code for Powder Free White, Black, and Purple Nitrile Examination Glove is LZA.

申請者としてS&S Glove Corporationを記載するその他の記録

K260703粉体不使用の青色ニトリル検査手袋 - 化学療法薬およびフェンタニルとの使用試験済み；粉体不使用の黑色ニトリル検査手袋 - 化学療法薬およびフェンタニルとの使用試験済み K223444粉体不使用のブルーニトリル検査手袋

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