FDA 510(k)

芬尼斯零柔膠粉塵無菌白色外科手術手套

K 號：K171987 · 2017-10-20

決定日期2017-10-20

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

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove is the device name listed in this FDA 510(k) record. The listed applicant is Lucenxia Prescience AG. It received FDA 510(k) clearance on 2017-10-20 under 510(k) number K171987. 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 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove?

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Lucenxia Prescience AG. The 510(k) number is K171987.

When did Finessis Zero Flexylon Powder Free Sterile White Surgical Glove receive FDA 510(k) clearance?

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove received FDA 510(k) clearance on 2017-10-20, under 510(k) number K171987.

Who is the listed applicant for Finessis Zero Flexylon Powder Free Sterile White Surgical Glove?

The FDA 510(k) record lists Lucenxia Prescience AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Finessis Zero Flexylon Powder Free Sterile White Surgical Glove?

The FDA product code for Finessis Zero Flexylon Powder Free Sterile White Surgical Glove is KGO.

其他以 Lucenxia Prescience AG 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。

K173304芬尼斯強力聚異戊二烯外科手套 K173386Finessis 零彈性 Flexylon 遮菌白術術手套，已經通過與化學治療藥物使用的測試 K162852芬尼斯零化學柔絲粉塵無菌白色外科手術手套

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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