FDA 510(k)

藍色非消毒粉塵無乳膠檢查手套，經測試可與化療藥物、胃酸及芬太尼使用。

K 號：K230681 · 2023-10-02

決定日期2023-10-02

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

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Central Medicare Sdn Bhd. It received FDA 510(k) clearance on 2023-10-02 under 510(k) number K230681. 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 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl?

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl is a medical device that received FDA 510(k) clearance on 2023-10-02. The listed applicant is Central Medicare Sdn Bhd. The 510(k) number is K230681.

When did Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl receive FDA 510(k) clearance?

Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl received FDA 510(k) clearance on 2023-10-02, under 510(k) number K230681.

Who is the listed applicant for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl?

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

What is the FDA product code for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl?

The FDA product code for Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl is LZA.