FDA 510(k)

氰化物無粉檢查手套（藍色），非无菌低皮膚炎潛在風險

K 號：K241528 · 2024-08-06

申請人Comfort Rubber Gloves Industries Sdn. Bhd.

決定日期2024-08-06

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 (Blue), Non-Sterile Low Dermatitis Potential is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2024-08-06 under 510(k) number K241528. 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 (Blue), Non-Sterile Low Dermatitis Potential?

Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical device that received FDA 510(k) clearance on 2024-08-06. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K241528.

When did Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential received FDA 510(k) clearance on 2024-08-06, under 510(k) number K241528.

Who is the listed applicant for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential?

The FDA 510(k) record lists Comfort Rubber Gloves Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential?

The FDA product code for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is LZA.

其他以 Comfort Rubber Gloves Industries 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。

K250069無粉天然橡膠檢查手套 – 藍色，非无菌，每平方分米50微克或以下蛋白質聲明 K240269氮化膽矽無粉檢查手套生物可降解（綠色）K192954無電力尼龍檢查手套，已檢驗適合與化療藥物及芬太尼使用 K200181黑色無粉乳膠檢查手套，已經通過與化療藥物及芬太尼鹽酸鹽的相容性測試 K190080無粉劑氰膠檢查手套，適用於化學治療藥物使用之檢驗標籤聲明（黑色）K180476無粉劑氰膠檢查手套，已檢驗適合與化療藥物使用

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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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