FDA 510(k)

一次性消毒乳膠外科手套

K 號：K211953 · 2022-05-25

申請人Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

決定日期2022-05-25

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

Disposable Sterilized Latex Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K211953. 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 Disposable Sterilized Latex Surgical Gloves?

Disposable Sterilized Latex Surgical Gloves is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. The 510(k) number is K211953.

When did Disposable Sterilized Latex Surgical Gloves receive FDA 510(k) clearance?

Disposable Sterilized Latex Surgical Gloves received FDA 510(k) clearance on 2022-05-25, under 510(k) number K211953.

Who is the listed applicant for Disposable Sterilized Latex Surgical Gloves?

The FDA 510(k) record lists Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Sterilized Latex Surgical Gloves?

The FDA product code for Disposable Sterilized Latex Surgical Gloves is KGO.

其他以 Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. 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。

K214017檢驗手套-型A(乳膠手套)K212290檢查手套 - 型號C（尼龍手套）

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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