FDA 510(k)

GenaCheck™ 硅膠無粉檢查手套，適用於與化學治療藥物及芬太尼鹽酸（XS/S/M/L/XL）使用之檢驗。

K 號：K240545 · 2024-08-28

決定日期2024-08-28

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

GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) is the device name listed in this FDA 510(k) record. The listed applicant is Genabio Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-08-28 under 510(k) number K240545. 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 GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)?

GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) is a medical device that received FDA 510(k) clearance on 2024-08-28. The listed applicant is Genabio Diagnostics, Inc.. The 510(k) number is K240545.

When did GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) receive FDA 510(k) clearance?

GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) received FDA 510(k) clearance on 2024-08-28, under 510(k) number K240545.

Who is the listed applicant for GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)?

The FDA 510(k) record lists Genabio Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)?

The FDA product code for GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) is LZA.

其他以 Genabio Diagnostics, Inc. 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。

K251753GenaCheck COVID-19 快速自測包

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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