FDA 510(k)

氰化物無粉塵檢查手套，含茯苓提取物，適用於與化療藥物及芬太尼鹽酸鹽使用 - 藍色

K 號：K243694 · 2025-06-06

決定日期2025-06-06

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

Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue is the device name listed in this FDA 510(k) record. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K243694. 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 Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue?

Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. The 510(k) number is K243694.

When did Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue receive FDA 510(k) clearance?

Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue received FDA 510(k) clearance on 2025-06-06, under 510(k) number K243694.

Who is the listed applicant for Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue?

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

What is the FDA product code for Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue?

The FDA product code for Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue is LZA.

其他以 Mah Sing Healthcare 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。

K230002氮化膽粉無粉黑病人檢查手套，非无菌，已測試與化療藥物使用 K223415氰化粉末無菌藍色病人檢查手套，非无菌，已檢驗可與化療藥物及芬太尼鹽酸使用 K214110氰化物無粉藍色病人檢查手套非無菌，已檢驗適合與化療藥物使用 K212535氰化物無粉藍色檢查手套，非无菌

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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