FDA 510(k)

無粉白色藍色消毒尼龍共聚物檢查手套，已檢驗可與化療藥物使用

K 號：K183280 · 2019-07-26

決定日期2019-07-26

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

PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs is the device name listed in this FDA 510(k) record. The listed applicant is Smart Glove Corporation Sdn. Bhd.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K183280. 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 PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs?

PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Smart Glove Corporation Sdn. Bhd.. The 510(k) number is K183280.

When did PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs receive FDA 510(k) clearance?

PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs received FDA 510(k) clearance on 2019-07-26, under 510(k) number K183280.

Who is the listed applicant for PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs?

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

What is the FDA product code for PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs?

The FDA product code for PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs is LZA.

其他以 Smart Glove Corporation 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。

K213373無粉塵綠色生物可降解丁腈檢查手套，已測試與化療藥物及芬太尼鹽酸使用 Compatibility K181047無粉白色、藍色消毒尼龍共聚物外科手套，已測試與化療藥物使用 Compatibility K180221無粉白色、綠色消毒多氯丙烯共聚物外科手套 - 已測試與化療藥物使用 K171743無粉塵粉紅色多氯乙烯共聚物檢查手套，無粉塵黑色多氯乙烯共聚物檢查手套

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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