FDA 510(k)

Kindguard 非粉塵膠皮病人檢查手套，透明（非顏色）

K 號：K173017 · 2017-12-15

申請人Anhui Kindguard Medical Supplies Technology Co., Ltd.

決定日期2017-12-15

產品代碼LYZ

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

Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Kindguard Medical Supplies Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K173017. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Anhui Kindguard Medical Supplies Technology Co., Ltd.. The 510(k) number is K173017.

When did Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) receive FDA 510(k) clearance?

Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) received FDA 510(k) clearance on 2017-12-15, under 510(k) number K173017.

Who is the listed applicant for Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

The FDA 510(k) record lists Anhui Kindguard Medical Supplies Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

The FDA product code for Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is LYZ.

其他以 Anhui Kindguard Medical Supplies Technology 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。

K223281一次性尼龍檢查手套 K173016Kindguard 非粉塵膠皮病人檢查手套，淺黃色

相關器械（代碼：LYZ）

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。

K260860無粉合成乙烯基檢查手套（藍色、黑色）Basic Medical Technology, Inc.K252467一次性膠質檢查手套Viet Phu Trade and Import Export Co., Ltd.K252505無粉觸感乙烯基檢查手套，透明Basic Medical Technology, Inc.K241252一次性膠質檢查手套Anqing Pukang Medical Technology Co., Ltd.K230046乙烯檢查手套Guangdong Kingfa Sci. & Tech.Co., Ltd.K221980一次性無粉膠製檢查手套，米色/透明Ever Global (Vietnam) Enterprise Corporation

官方來源

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