FDA 510(k)

Halyard 紫色尼龍無粉檢查手套，適用於化學治療藥物

K 號：K182096 · 2018-11-02

決定日期2018-11-02

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

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Owens & Minor Halyard, Inc.. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K182096. 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 Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs?

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Owens & Minor Halyard, Inc.. The 510(k) number is K182096.

When did Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-11-02, under 510(k) number K182096.

Who is the listed applicant for Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Owens & Minor Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs?

The FDA product code for Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs is LZA.

其他以 Owens & Minor Halyard, Inc. 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。

K181959HALYARD 智能折疊* 過濾包裝 (H450, H650)

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

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