FDA 510(k)

無菌外科粉末觸感乳膠手套

K 號：K221424 · 2023-01-26

決定日期2023-01-26

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 Surgical Powder Free Latex Glove is the device name listed in this FDA 510(k) record. The listed applicant is New Era Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K221424. 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 Surgical Powder Free Latex Glove?

Sterile Surgical Powder Free Latex Glove is a medical device that received FDA 510(k) clearance on 2023-01-26. The listed applicant is New Era Medicare Sdn. Bhd.. The 510(k) number is K221424.

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

Sterile Surgical Powder Free Latex Glove received FDA 510(k) clearance on 2023-01-26, under 510(k) number K221424.

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

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

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

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

其他以 New Era 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。

K230314無菌無粉乳膠檢查手套（藍色、黑色及白色）K221667非无菌無粉乳膠檢查手套

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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