FDA 510(k)

無粉劑氰膠檢查手套（藍色），已檢驗可與化療藥物及芬太尼鹽酸（XS、S、M、L、XL、XXL）使用

K 號：K241970 · 2024-08-02

申請人Kanglongda Vietnam Protection Technology Company Limited

決定日期2024-08-02

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

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) is the device name listed in this FDA 510(k) record. The listed applicant is Kanglongda Vietnam Protection Technology Company Limited. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241970. 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 Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)?

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Kanglongda Vietnam Protection Technology Company Limited. The 510(k) number is K241970.

When did Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241970.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)?

The FDA 510(k) record lists Kanglongda Vietnam Protection Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)?

The FDA product code for Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) is LZA.

其他以 Kanglongda Vietnam Protection Technology Company Limited 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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