FDA 510(k)

藍色無粉氮化橡膠檢查手套，帶葡萄香氣，化學治療藥物及芬太尼檢測聲稱

K 號：K220672 · 2022-06-03

決定日期2022-06-03

產品代碼LZA

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim is the device name listed in this FDA 510(k) record. The listed applicant is Riverstone Resources Sdn Bhd. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K220672. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim?

Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Riverstone Resources Sdn Bhd. The 510(k) number is K220672.

When did Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim receive FDA 510(k) clearance?

Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim received FDA 510(k) clearance on 2022-06-03, under 510(k) number K220672.

Who is the listed applicant for Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim?

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

What is the FDA product code for Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim?

The FDA product code for Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim is LZA.

其他以 Riverstone Resources Sdn Bhd 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：LZA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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