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FDA 510(k)

無粉劑氰膽素檢查手套，（钴藍色和紫羅蘭藍色），無粉劑橡膠檢查手套

K 號：K221229 · 2022-07-16

申請人Zibo Blue Sail Health Technology Co., Ltd.
決定日期2022-07-16
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 Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Blue Sail Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-16 under 510(k) number K221229. 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 Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves?

Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-07-16. The listed applicant is Zibo Blue Sail Health Technology Co., Ltd.. The 510(k) number is K221229.

When did Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves received FDA 510(k) clearance on 2022-07-16, under 510(k) number K221229.

Who is the listed applicant for Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves?

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

What is the FDA product code for Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves?

The FDA product code for Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves is LZA.

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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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