FDA 510(k)

非无菌、無粉乳膠檢查手套，低皮膚炎潛在風險，並經過與化療藥物使用的測試藍-AC

K 號：K200453 · 2020-05-01

決定日期2020-05-01

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

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC is the device name listed in this FDA 510(k) record. The listed applicant is Yty Industry (Manjung) Sdn Bhd. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K200453. 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 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC?

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Yty Industry (Manjung) Sdn Bhd. The 510(k) number is K200453.

When did NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC receive FDA 510(k) clearance?

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC received FDA 510(k) clearance on 2020-05-01, under 510(k) number K200453.

Who is the listed applicant for NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC?

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

What is the FDA product code for NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC?

The FDA product code for NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC is LZA.

其他以 Yty Industry (Manjung) 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。

K220644非无菌、無粉、雙手適用、有紋理、珠狀袖口、一次性使用，Doffy® 硝基化學檢查手套，已檢驗可與化學治療藥物使用 K202536非无菌、無粉乳膠檢查手套，低皮膚炎潛在風險，已檢驗適合與化療藥物使用，以及非无菌、無粉乳膠檢查手套，已檢驗適合與化療藥物及芬太尼鹽酸使用。K182383非無菌、PF 硝基膠檢查手套，已測試與化療藥物使用兼容-藍色 K171104非無菌、無粉劑氰膠檢查手套，已測試與化療藥物使用相容（藍色、钴藍色）K162095非无菌、無粉乳膠檢查手套，適用於化學治療藥物測試（原藍色、钴藍色）

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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