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FDA 510(k)

一次性硝基橡胶檢查手套（非無菌）（QN-N001、QN-N002、QN-N003、QN-N004、QN-N005）

K 號：K240824 · 2024-06-25

申請人Ningxia Qiaoen Medical Technology Co., Ltd.
決定日期2024-06-25
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

Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) is the device name listed in this FDA 510(k) record. The listed applicant is Ningxia Qiaoen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-25 under 510(k) number K240824. 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 Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)?

Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) is a medical device that received FDA 510(k) clearance on 2024-06-25. The listed applicant is Ningxia Qiaoen Medical Technology Co., Ltd.. The 510(k) number is K240824.

When did Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) receive FDA 510(k) clearance?

Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) received FDA 510(k) clearance on 2024-06-25, under 510(k) number K240824.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)?

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

What is the FDA product code for Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)?

The FDA product code for Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) is LZA.

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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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