FDA 510(k)

經化學治療藥物使用測試的無粉塵聚異丁烯外科手套

K 號：K171898 · 2017-08-18

申請人Better Care Plastic Technology Co., Ltd.

決定日期2017-08-18

產品代碼KGO

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Better Care Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K171898. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs?

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Better Care Plastic Technology Co., Ltd.. The 510(k) number is K171898.

When did Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs receive FDA 510(k) clearance?

Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs received FDA 510(k) clearance on 2017-08-18, under 510(k) number K171898.

Who is the listed applicant for Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs?

The FDA 510(k) record lists Better Care Plastic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs?

The FDA product code for Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs is KGO.

其他以 Better Care Plastic Technology Co., Ltd. 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。

K242533無粉劑氰膠病人檢查手套，藍色，非无菌，低皮膚炎潛在風險。已檢驗與化療藥物及芬太尼鹽酸使用。K232266無粉劑氰膠病人檢查手套，藍色，非无菌，已測試與化療藥物及芬太尼鹽酸使用 K232070可生物降解的尼龍檢查手套，經測試適合與化療藥物及芬太尼鹽酸（黑色、綠色）使用 K231567可生物降解尼龍粉末免洗檢查手套，適用於化學治療藥物、芬太尼鹽酸鹽及選擇性其他藥物（藍色）測試使用 K223713無粉乳膠檢查手套（灰色）已測試與化療藥物及芬太尼鹽酸使用 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

查看所有 10 項裝置 →

相關器械（代碼：KGO）

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。

K260558乳膠無粉外科手術手套，已經通過與化學治療藥物及芬太尼鹽酸鹽的合用測試；含膠狀燕麥粉的乳膠無粉外科手術手套，已經通過與化學治療藥物及芬太尼鹽酸鹽的合用測試Hartalega NGC Sdn. Bhd.K253060無菌乳膠無粉外科手套Protect Gloves Company Limited K250313無菌粉末釋放合成橡膠外科醫用手套，綠色，已測試與化療藥物及胃酸使用相容Harps Europe Manufacturing GmbH K240790多異戊二烯外科手套Suzhou Colour-Way New Material Co., Ltd.K232079天然橡膠乳膠外科手套，無粉，无菌，已測試與化療藥物及芬太尼（綠色）相容；天然橡膠乳膠（去膜&塗層）/（去膜&包裝）外科手套，無粉，无菌，已測試與化療藥物及芬太尼相容Wrp Asia Pacific Sdn. Bhd.K232444無菌無粉乳膠外科手套，已檢驗適合與化療藥物使用Grand Work Plastic Products Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。