FDA 510(k)

非无菌無粉聚氨酯檢查手套（藍色和黑色）

K 號：K203036 · 2021-05-07

決定日期2021-05-07

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 Polyurethane Examination Gloves (Blue and Black colors) is the device name listed in this FDA 510(k) record. The listed applicant is Central Medicare Sdn Bhd. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K203036. 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 Polyurethane Examination Gloves (Blue and Black colors)?

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Central Medicare Sdn Bhd. The 510(k) number is K203036.

When did Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) receive FDA 510(k) clearance?

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) received FDA 510(k) clearance on 2021-05-07, under 510(k) number K203036.

Who is the listed applicant for Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)?

The FDA 510(k) record lists Central Medicare 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 Polyurethane Examination Gloves (Blue and Black colors)?

The FDA product code for Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) is LZA.

其他以 Central Medicare 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。

K230681藍色非消毒粉塵無乳膠檢查手套，經測試可與化療藥物、胃酸及芬太尼使用。K223752黑色非无菌粉塵無乳膠檢查手套，適用於與化療藥物使用，含氯喹、環孢素A、逆轉病毒、胃酸及芬太尼檢測。K230875藍色非無菌粉末無菌乳膠檢查手套，經化療藥物使用測試，具有胃酸和芬太尼通透性抗性聲明 K230564綠色非消毒無粉乳膠檢查手套 K213437藍色非無菌粉末無菌乳膠檢查手套，經化療藥物使用測試，具有胃酸和芬太尼通透性抗性聲明 K211022藍色非消毒粉塵型尼龍檢查手套，已測試與化療藥物使用，並具有胃酸及芬太尼通透性抵抗聲明。

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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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