FDA 510(k)

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

K 號：K214110 · 2022-02-19

決定日期2022-02-19

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 Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs 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 2022-02-19 under 510(k) number K214110. 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 Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs?

Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. The 510(k) number is K214110.

When did Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs receive FDA 510(k) clearance?

Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs received FDA 510(k) clearance on 2022-02-19, under 510(k) number K214110.

Who is the listed applicant for Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs?

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 Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs?

The FDA product code for Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs is LZA.

其他以 Mah Sing Healthcare Sdn. Bhd. 為申請人之記錄

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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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