免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Biogel Skinsense Indicator 下手套，Biogel PI Ultratouch，Biogel PI Indicator 下手套，Biogel PI，Biogel PI Micro

K 號：K193573 · 2020-04-10

申請人Molnlycke Health Care Us, LLC
決定日期2020-04-10
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

Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2020-04-10 under 510(k) number K193573. 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 Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro?

Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro is a medical device that received FDA 510(k) clearance on 2020-04-10. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K193573.

When did Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro receive FDA 510(k) clearance?

Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro received FDA 510(k) clearance on 2020-04-10, under 510(k) number K193573.

Who is the listed applicant for Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro?

The FDA 510(k) record lists Molnlycke Health Care Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro?

The FDA product code for Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro is KGO.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Molnlycke Health Care Us, LLC 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。

K232508防護易暖活體自暖毛毯K203369Avance 獨立負壓創傷治療系統 (NPWT)K202090Biogel Eclipse / Biogel Eclipse 指示性下手套，Biogel 外科醫師 / Biogel 指示性下手套，Biogel PI 微型指示下手套，Biogel PI UltraTouch S 外科手套，具有低皮膚炎潛在風險聲明，Biogel PI UltraTouch S 指示性下手套，具有低皮膚炎潛在風險聲明K191869Biogel(R) PI UltraTouch S 外科手套，具有低皮炎潜力聲稱，Biogel(R) PI UltraTouch S 指示式內手套，具有低皮炎潜力聲稱K190077Biogel® PI UltraTouch S 外科手套，Biogel® Pl Ultra Touch S 指示式內手套K161939Avance 腹部敷料組合包

查看所有 12 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 LimitedK250313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 GmbHK240790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。

↑