FDA 510(k)

無菌乳膠外科手套，無粉

K 號：K190241 · 2019-12-30

決定日期2019-12-30

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 Latex Surgical Glove, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2019-12-30 under 510(k) number K190241. 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 Latex Surgical Glove, Powder Free?

Sterile Latex Surgical Glove, Powder Free is a medical device that received FDA 510(k) clearance on 2019-12-30. The listed applicant is Careglove Global Sdn. Bhd.. The 510(k) number is K190241.

When did Sterile Latex Surgical Glove, Powder Free receive FDA 510(k) clearance?

Sterile Latex Surgical Glove, Powder Free received FDA 510(k) clearance on 2019-12-30, under 510(k) number K190241.

Who is the listed applicant for Sterile Latex Surgical Glove, Powder Free?

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

What is the FDA product code for Sterile Latex Surgical Glove, Powder Free?

The FDA product code for Sterile Latex Surgical Glove, Powder Free is KGO.

其他以 Careglove Global 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。

K250578奈爾酮檢查手套無粉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 K230121奈爾酮檢查手套無粉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 K220859無粉乳膠檢查手套，彩色（綠色、橙色、紫色、白色及黑色）K213993無粉塵氯丁橡胶檢查手套（藍色、綠色）K211666無粉乳膠檢查手套，藍色化學測試 K172015無粉乳膠檢查手套，藍色（彩色）

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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

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