FDA 510(k)

一次性聚氯乙烯檢查手套

K 號：K220469 · 2022-06-16

申請人Chifeng Huawei Medical Science&Technology Co., Ltd.

決定日期2022-06-16

產品代碼LYZ

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 Vinyl Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Chifeng Huawei Medical Science&Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K220469. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Vinyl Examination Glove?

Disposable Vinyl Examination Glove is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Chifeng Huawei Medical Science&Technology Co., Ltd.. The 510(k) number is K220469.

When did Disposable Vinyl Examination Glove receive FDA 510(k) clearance?

Disposable Vinyl Examination Glove received FDA 510(k) clearance on 2022-06-16, under 510(k) number K220469.

Who is the listed applicant for Disposable Vinyl Examination Glove?

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

What is the FDA product code for Disposable Vinyl Examination Glove?

The FDA product code for Disposable Vinyl Examination Glove is LYZ.

其他以 Chifeng Huawei Medical Science&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。

K212833一次性尼龍檢查手套

相關器械（代碼：LYZ）

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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