FDA 510(k)

Biogel® PI UltraTouch S 外科手套，Biogel® Pl Ultra Touch S 指示式內手套

K 號：K190077 · 2019-05-24

決定日期2019-05-24

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® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove 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 2019-05-24 under 510(k) number K190077. 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® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove?

Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K190077.

When did Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove receive FDA 510(k) clearance?

Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove received FDA 510(k) clearance on 2019-05-24, under 510(k) number K190077.

Who is the listed applicant for Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove?

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® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove?

The FDA product code for Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove is KGO.

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 K193573Biogel Skinsense Indicator 下手套，Biogel PI Ultratouch，Biogel PI Indicator 下手套，Biogel PI，Biogel PI Micro 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 K161939Avance 腹部敷料組合包

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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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