FDA 510(k)

Microflex 硝基病人檢查手套，含洋甘菊和金合歡，藍綠粉三色，已經檢測過

K 號：K200671 · 2020-06-19

決定日期2020-06-19

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

Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2020-06-19 under 510(k) number K200671. 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 Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for?

Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for is a medical device that received FDA 510(k) clearance on 2020-06-19. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K200671.

When did Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for receive FDA 510(k) clearance?

Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for received FDA 510(k) clearance on 2020-06-19, under 510(k) number K200671.

Who is the listed applicant for Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for?

The FDA product code for Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for is LZA.

其他以 Ansell Healthcare Products, LLC 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。

K230079多異戊二烯外科手套，經測試適合與化療藥物使用並具有低皮膚炎潛在風險 K213289Gammex® PI Plus Glove-in-Glove™ 系統已經通過測試，適合與化學治療藥物使用 K212148非无菌無粉多氯丙烯檢查手套（藍色）已檢驗適合與化療藥物使用 K210401Microflex 硝基膠病人檢查手套藍色款已經測試可用於化療藥物及芬太尼鹽酸鹽，Microflex 硝基膠病人檢查手套綠色款已經測試可用於化療藥物及芬太尼鹽酸鹽，Microflex 硝基膠病人檢查手套黑色款已經測試可用於化療藥物及芬太尼鹽酸鹽 K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves 經測試可用於化療藥物 K182948Gammex PI雙用外科手套，已經通過與化學治療藥物的使用測試

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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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