FDA 510(k)

無粉乳膠檢查手套，蛋白質標籤聲稱為每平方分米50ug或以下

K 號：K162175 · 2016-11-21

決定日期2016-11-21

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 Glove with Protein Labeling Claim of 50ug/dm2 or less is the device name listed in this FDA 510(k) record. The listed applicant is Vietglove Corporation. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K162175. 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 Glove with Protein Labeling Claim of 50ug/dm2 or less?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Vietglove Corporation. The 510(k) number is K162175.

When did Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less receive FDA 510(k) clearance?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less received FDA 510(k) clearance on 2016-11-21, under 510(k) number K162175.

Who is the listed applicant for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

The FDA 510(k) record lists Vietglove Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

The FDA product code for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is LYY.

其他以 Vietglove Corporation 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。

K201428無粉黑氮化膽固醇檢查手套 K170094無粉乳膠檢查手套，聚合物塗層 K153562無粉藍色尼龍檢查手套

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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