FDA 510(k)

KS 內科醫療無粉塵丁腈檢查手套，非无菌，適用於化療藥物測試（藍色、黑色）

K 號：K171171 · 2018-02-22

決定日期2018-02-22

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

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) is the device name listed in this FDA 510(k) record. The listed applicant is Koon Seng Sdn Bhd. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K171171. 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 KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)?

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Koon Seng Sdn Bhd. The 510(k) number is K171171.

When did KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) receive FDA 510(k) clearance?

KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) received FDA 510(k) clearance on 2018-02-22, under 510(k) number K171171.

Who is the listed applicant for KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)?

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

What is the FDA product code for KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)?

The FDA product code for KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) is LZA.

其他以 Koon Seng 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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