FDA 510(k)

乳膠檢驗手套，無粉

K 號：K213509 · 2022-04-08

申請人Shandong Intco Medical Products Co, Ltd.

決定日期2022-04-08

產品代碼LYY

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

Latex Examination Gloves, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Intco Medical Products Co, Ltd.. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K213509. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Latex Examination Gloves, Powder Free?

Latex Examination Gloves, Powder Free is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Shandong Intco Medical Products Co, Ltd.. The 510(k) number is K213509.

When did Latex Examination Gloves, Powder Free receive FDA 510(k) clearance?

Latex Examination Gloves, Powder Free received FDA 510(k) clearance on 2022-04-08, under 510(k) number K213509.

Who is the listed applicant for Latex Examination Gloves, Powder Free?

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

What is the FDA product code for Latex Examination Gloves, Powder Free?

The FDA product code for Latex Examination Gloves, Powder Free is LYY.

其他以 Shandong Intco Medical Products Co, Ltd. 為申請人之記錄

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相關器械（代碼：LYY）

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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