FDA 510(k)

無粉乳膠檢查手套

K 號：K222612 · 2022-11-25

申請人Guangdong Kingfa Sci. & Tech.Co., Ltd.

決定日期2022-11-25

產品代碼LYY

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Powder-Free Latex examination gloves is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2022-11-25 under 510(k) number K222612. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Powder-Free Latex examination gloves?

Powder-Free Latex examination gloves is a medical device that received FDA 510(k) clearance on 2022-11-25. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K222612.

When did Powder-Free Latex examination gloves receive FDA 510(k) clearance?

Powder-Free Latex examination gloves received FDA 510(k) clearance on 2022-11-25, under 510(k) number K222612.

Who is the listed applicant for Powder-Free Latex examination gloves?

The FDA 510(k) record lists Guangdong Kingfa Sci. & Tech.Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder-Free Latex examination gloves?

The FDA product code for Powder-Free Latex examination gloves is LYY.

其他以 Guangdong Kingfa Sci. & Tech.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。

K233723醫療外科口罩 K231155可生物降解醫用外科口罩 K221983可生物降解無粉乳膠檢查手套，藍色，可生物降解無粉乳膠檢查手套，藍紫色，可生物降解無粉乳膠檢查手套，綠色 K230046乙烯檢查手套 K222714藍色丁腈病人檢查手套，適用於化學治療藥物檢驗，藍紫色丁腈病人檢查手套，適用於化學治療藥物檢驗，黑色丁腈病人檢查手套，適用於化學治療藥物檢驗 K221887奈爾烯檢查手套，粉紅色；奈爾烯檢查手套，黑色；奈爾烯檢查手套，白色

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相關器械（代碼：LYY）

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。

K250069無粉天然橡膠檢查手套 – 藍色，非无菌，每平方分米50微克或以下蛋白質聲明Comfort Rubber Gloves Industries Sdn. Bhd.K240266乳膠檢查手套無粉（海洋藍色及自然白色）Sri Trang Gloves (Thailand) Public Company Limited K230573無粉乳膠病人檢查手套，黑色，非无菌，並標示蛋白質含量聲明（每平方分米手套含50微克或更少的總可提取蛋白質）Kossan International Sdn Bhd K223298無菌乳膠檢查手套無粉 (S, M, L, 超大L)Shandong Intco Medical Products Co, Ltd.K221667非无菌無粉乳膠檢查手套New Era Medicare Sdn. Bhd.K222348JR MEDICJr Engineering & Medical Technologies (M) Sdn. Bhd.

官方來源

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