FDA 510(k)

無粉塵、非无菌、藍色丁腈檢查手套，已測試與化療藥物及芬太尼使用相容

K 號：K233520 · 2024-01-12

申請人Anhui Powerguard Technology Co., Ltd.

決定日期2024-01-12

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, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Powerguard Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233520. 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, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl?

Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Anhui Powerguard Technology Co., Ltd.. The 510(k) number is K233520.

When did Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl receive FDA 510(k) clearance?

Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233520.

Who is the listed applicant for Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl?

The FDA 510(k) record lists Anhui Powerguard Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl?

The FDA product code for Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl is LZA.

其他以 Anhui Powerguard Technology Co., Ltd. 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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