FDA 510(k)

一次性醫用尼龍檢查手套 - 已測試與化療藥物使用

K 號：K213325 · 2022-01-28

申請人Anhui Xinyisheng Medical Technology Co.,Ltd

決定日期2022-01-28

產品代碼LZC

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- Tested for Use With Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Xinyisheng Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K213325. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs?

Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Anhui Xinyisheng Medical Technology Co.,Ltd. The 510(k) number is K213325.

When did Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs receive FDA 510(k) clearance?

Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs received FDA 510(k) clearance on 2022-01-28, under 510(k) number K213325.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs?

The FDA 510(k) record lists Anhui Xinyisheng 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- Tested for Use With Chemotherapy Drugs?

The FDA product code for Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs is LZC.

其他以 Anhui Xinyisheng Medical Technology Co.,Ltd 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。

K213371一次性硝基橡胶檢查手套（型號：XYS-001）

相關器械（代碼：LZC）

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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