FDA 510(k)

第二代尼龍檢查手套（藍色）具有低皮膚炎潛在風險聲明，並經測試適合與化療藥物使用聲明

K 號：K193121 · 2020-03-20

決定日期2020-03-20

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

GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims is the device name listed in this FDA 510(k) record. The listed applicant is Eco Medi Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K193121. 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 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims?

GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K193121.

When did GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims receive FDA 510(k) clearance?

GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193121.

Who is the listed applicant for GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims?

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

What is the FDA product code for GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims?

The FDA product code for GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims is LZA.