FDA 510(k)

無粉乳膠檢查手套，彩色（綠色、橙色、紫色、白色及黑色）

K 號：K220859 · 2022-09-09

決定日期2022-09-09

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, Colored (Green, Orange, Purple, White, & Black) is the device name listed in this FDA 510(k) record. The listed applicant is Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2022-09-09 under 510(k) number K220859. 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, Colored (Green, Orange, Purple, White, & Black)?

Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) is a medical device that received FDA 510(k) clearance on 2022-09-09. The listed applicant is Careglove Global Sdn. Bhd.. The 510(k) number is K220859.

When did Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) received FDA 510(k) clearance on 2022-09-09, under 510(k) number K220859.

Who is the listed applicant for Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)?

The FDA 510(k) record lists Careglove Global Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)?

The FDA product code for Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) is LZA.

其他以 Careglove Global Sdn. Bhd. 為申請人之記錄

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相關器械（代碼：LZA）

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