FDA 510(k)

單次使用乳膠無菌外科手套（SG100）

K 號：K231446 · 2023-09-22

申請人Fitone Latex Products Co., Ltd. Guangdong

決定日期2023-09-22

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

Single-Use Latex Sterile Surgical Gloves (SG100) is the device name listed in this FDA 510(k) record. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231446. 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 Single-Use Latex Sterile Surgical Gloves (SG100)?

Single-Use Latex Sterile Surgical Gloves (SG100) is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Fitone Latex Products Co., Ltd. Guangdong. The 510(k) number is K231446.

When did Single-Use Latex Sterile Surgical Gloves (SG100) receive FDA 510(k) clearance?

Single-Use Latex Sterile Surgical Gloves (SG100) received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231446.

Who is the listed applicant for Single-Use Latex Sterile Surgical Gloves (SG100)?

The FDA 510(k) record lists Fitone Latex Products Co., Ltd. Guangdong as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Latex Sterile Surgical Gloves (SG100)?

The FDA product code for Single-Use Latex Sterile Surgical Gloves (SG100) is KGO.

其他以 Fitone Latex Products Co., Ltd. Guangdong 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。

K221747奈爾酮病人檢查手套，已經通過與化學治療藥物使用的測試 K222693單次使用醫療橡膠檢查手套（LG100）K211927奈爾斯檢查手套

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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