FDA 510(k)

Brightway品牌，尼龍檢查手套，無粉（藍色），已檢驗可用於化療藥物及芬太尼鹽

K 號：K211816 · 2022-11-02

決定日期2022-11-02

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

Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Brightway Holdings Sdn. Bhd.. It received FDA 510(k) clearance on 2022-11-02 under 510(k) number K211816. 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 Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2022-11-02. The listed applicant is Brightway Holdings Sdn. Bhd.. The 510(k) number is K211816.

When did Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate receive FDA 510(k) clearance?

Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2022-11-02, under 510(k) number K211816.

Who is the listed applicant for Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

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

What is the FDA product code for Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is LZA.