FDA 510(k)

Amazing+ 胶乳檢驗無粉手套

K 號：K212597 · 2022-05-28

決定日期2022-05-28

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

Amazing+ Latex Examination Powder Free Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Amazing Rubber Products Pvt, Ltd.. It received FDA 510(k) clearance on 2022-05-28 under 510(k) number K212597. 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 Amazing+ Latex Examination Powder Free Gloves?

Amazing+ Latex Examination Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2022-05-28. The listed applicant is Amazing Rubber Products Pvt, Ltd.. The 510(k) number is K212597.

When did Amazing+ Latex Examination Powder Free Gloves receive FDA 510(k) clearance?

Amazing+ Latex Examination Powder Free Gloves received FDA 510(k) clearance on 2022-05-28, under 510(k) number K212597.

Who is the listed applicant for Amazing+ Latex Examination Powder Free Gloves?

The FDA 510(k) record lists Amazing Rubber Products Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amazing+ Latex Examination Powder Free Gloves?

The FDA product code for Amazing+ Latex Examination Powder Free Gloves is LYY.

其他以 Amazing Rubber Products Pvt, 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。

K212584藍色尼龍檢查手套非粉塵 K212596無菌乳膠外科手套非粉化 K212586Amazing+

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.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.

官方來源

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