FDA 510(k)

乳膠檢查手套無粉（海洋藍色及自然白色）

K 號：K240266 · 2024-09-09

申請人Sri Trang Gloves (Thailand) Public Company Limited

決定日期2024-09-09

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

Latex Examination Glove Powder Free (Ocean Blue and Natural White) is the device name listed in this FDA 510(k) record. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. It received FDA 510(k) clearance on 2024-09-09 under 510(k) number K240266. 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 Latex Examination Glove Powder Free (Ocean Blue and Natural White)?

Latex Examination Glove Powder Free (Ocean Blue and Natural White) is a medical device that received FDA 510(k) clearance on 2024-09-09. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K240266.

When did Latex Examination Glove Powder Free (Ocean Blue and Natural White) receive FDA 510(k) clearance?

Latex Examination Glove Powder Free (Ocean Blue and Natural White) received FDA 510(k) clearance on 2024-09-09, under 510(k) number K240266.

Who is the listed applicant for Latex Examination Glove Powder Free (Ocean Blue and Natural White)?

The FDA 510(k) record lists Sri Trang Gloves (Thailand) Public Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Latex Examination Glove Powder Free (Ocean Blue and Natural White)?

The FDA product code for Latex Examination Glove Powder Free (Ocean Blue and Natural White) is LYY.

其他以 Sri Trang Gloves (Thailand) Public Company Limited 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。

K240930非无菌、無粉乳膠檢查手套，已測試與55種化學治療藥物及芬太尼相容 - 紫藍色；非无菌、無粉乳膠檢查手套，已測試與55種化學治療藥物及芬太尼相容 - 藍色 K232614非无菌、無粉乳膠檢查手套，適用於化學治療藥物及芬太尼檢測（白色、黑色及紫羅蘭藍色）K221165非無菌、無粉劑氰膽胺檢查手套紫藍色，已檢驗可用於化療藥物及芬太尼；非無菌、無粉劑氰膽胺檢查手套藍色，已檢驗可用於化療藥物及芬太尼 K212482非无菌、無粉乳膠檢查手套海洋藍、紫藍、黑色和自然白色 K212309非无菌、無粉乳膠檢查手套 K200539非无菌、無粉乳膠檢查手套，已測試與化療藥物及芬太尼使用相容

查看所有 8 項裝置 →

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.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.K222612無粉乳膠檢查手套Guangdong Kingfa Sci. & Tech.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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