FDA 510(k)

奈爾酮無粉 Exam Gloves，適用於化學治療藥物測試 - 紫藍色（VBLU）

K 號：K151997 · 2016-03-31

決定日期2016-03-31

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

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega NGC Sdn. Bhd.. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K151997. 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 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)?

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Hartalega NGC Sdn. Bhd.. The 510(k) number is K151997.

When did Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) received FDA 510(k) clearance on 2016-03-31, under 510(k) number K151997.

Who is the listed applicant for Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)?

FDA 510(k) 記錄將 Hartalega NGC Sdn. Bhd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)?

The FDA product code for Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) is LZA.

其他以 Hartalega NGC Sdn. Bhd. 為申請人之記錄

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。

查看所有 24 項裝置 →

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。

K261793無粉劑式尼龍檢查手套，適用於化學治療藥物及芬太尼鹽酸鹽（藍色及黑色）測試使用Maxter Healthcare, Inc.K262542可生物降解尼龍粉末免洗檢查手套，綠色；可生物降解尼龍粉末免洗檢查手套，紫藍色；經測試可與32種化學治療藥物、芬太尼及胃酸通透性抗性聲明相容Top Glove Sdn. Bhd.K260312奈米爾烯無粉塵檢查手套，藍色；經測試可用於32種化學治療藥物及芬太尼滲透阻礙聲明；奈米爾烯無粉塵檢查手套，紫藍色；經測試可用於32種化學治療藥物、西拉嗪、芬太尼及胃酸Gmp Medicare Sdn. Bhd.K261749卡迪那爾健康公司尼龍藍色檢查手套，已經通過與化學療法藥物和芬太尼鹽酸鹽的測試。Cardinalhealth K260794非无菌無粉硝基膽甾醇患者檢查手套，含甘草根提取物及尿素，經測試適合與化療藥物、芬太尼鹽酸鹽、盐酸氯噻嗪及胃酸使用。海洋色Kossan International Sdn Bhd K262014PUREZERO* MARIN* 硅膠無粉檢查手套；PUREZERO* MARIN-XTRA* 硅膠無粉檢查手套O&M Halyard, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。