FDA 510(k)

拉鋸術用手套，無粉且含有蛋白質聲稱（50微克或以下）

K 號：K211621 · 2021-10-06

決定日期2021-10-06

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

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) is the device name listed in this FDA 510(k) record. The listed applicant is Careplus (M) Sdn Bhd. It received FDA 510(k) clearance on 2021-10-06 under 510(k) number K211621. 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 Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)?

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) is a medical device that received FDA 510(k) clearance on 2021-10-06. The listed applicant is Careplus (M) Sdn Bhd. The 510(k) number is K211621.

When did Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) receive FDA 510(k) clearance?

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) received FDA 510(k) clearance on 2021-10-06, under 510(k) number K211621.

Who is the listed applicant for Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)?

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

What is the FDA product code for Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)?

The FDA product code for Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) is KGO.

其他以 Careplus (M) 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。

K201857無粉劑式尼龍檢查手套黑色及双色白藍 K203705乳膠檢查手套，無粉且含有蛋白質含量標示聲明（總可提取蛋白質50ug/g或以下）K210724ENCORE Latex Acclaim，無粉乳膠外科手套，具有蛋白質含量標籤聲明（每副手套含總水溶性蛋白質50 µg/dm2）並經測試適合與化療藥物使用，GAMMEX Latex Standard，無粉乳膠外科手套，具有蛋白質含量標籤聲明（每副手套含總水溶性蛋白質50 µg/dm2）並經測試適合與化療藥物使用 K210656ENCORE 機械人正畸，無粉乳膠外科手套，蛋白質含量標籤聲明（每副手套總水溶性蛋白質含量<50µg/dm2）並經測試適合與化療藥物使用，GAMMEX 機械人正畸，無粉乳膠外科手套，蛋白質含量標籤聲明（每副手套總水溶性蛋白質含量<50 µg/dm2）並經測試適合與化療藥物使用 K202765ENCORE 液體觸感外科手套，無粉無蛋白含量標示聲明（50微克或以下）並經過與化學治療藥物使用測試 K162858奈特瑞克硅橡胶檢查手套無粉，藍色，化學測試

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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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