FDA 510(k)

BRIGHTWAY品牌乳膠檢查手套 12英寸，無粉，[Sterling/灰色] 內含化療聲明

K 號：K162186 · 2017-03-31

決定日期2017-03-31

產品代碼LZC

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

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Brightway Holdings Sdn. Bhd.. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K162186. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM?

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Brightway Holdings Sdn. Bhd.. The 510(k) number is K162186.

When did BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM receive FDA 510(k) clearance?

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM received FDA 510(k) clearance on 2017-03-31, under 510(k) number K162186.

Who is the listed applicant for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM?

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

What is the FDA product code for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM?

The FDA product code for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is LZC.

其他以 Brightway Holdings 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。

K211816Brightway品牌，尼龍檢查手套，無粉（藍色），已檢驗可用於化療藥物及芬太尼鹽 K170686氮化膽脂檢查手套，無粉 [紫色] 已經測試過與化療藥物使用 K162294BRIGHTWAY品牌乳膠檢查手套 12英寸，無粉，[紫色] 驗證可用於化療藥物 K163267奈爾酮檢查手套 K162146Brightway品牌乳膠檢查手套，無粉（薰衣草色）K161215Brightway品牌乳膠檢查手套，無粉，[Sterling/灰色]已測試與化療藥物使用 Compatibility

查看所有 7 項裝置 →

相關器械（代碼：LZC）

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。

K252313卡迪那爾健康公司硅膠檢查手套長袖Cardinalhealth K243959無粉劑氰膠檢查手套（紫、黑、綠），已檢驗可與化療藥物、芬太尼鹽酸鹽及選擇其他藥物使用Lingshi Hongruida Health Protection Technology Co., Ltd.K221157JR醫療設備Jr Engineering & Medical Technologies (M) Sdn. Bhd.K222449奈爾酮粉末無菌檢查手套，適用於與化療藥物及芬太尼鹽酸（深藍色）使用測試Better Care Plastic Technology Co., Ltd.K220545無粉劑氰膽素檢查手套，藍色，已測試與化療藥物使用相容Hl Rubber Industries Sdn Bhd K220491一次性醫用尼龍檢查手套 - 已測試與化療藥物使用Hainan Asther Medical Equipment Co., Ltd.

官方來源

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