FDA 510(k)

一次性乳膠檢查手套（非無菌），一次性丁腈檢查手套（非無菌）

K 號：K203074 · 2021-11-19

決定日期2021-11-19

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

Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Universal Gloves. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K203074. 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 Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)?

Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Pt. Universal Gloves. The 510(k) number is K203074.

When did Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) receive FDA 510(k) clearance?

Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) received FDA 510(k) clearance on 2021-11-19, under 510(k) number K203074.

Who is the listed applicant for Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)?

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

What is the FDA product code for Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)?

The FDA product code for Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) is LYY.

其他以 Pt. Universal Gloves 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。

K211360一次性尼龍粉末無菌檢查手套（非无菌）K201576一次性無粉乳膠檢查手套（非无菌）

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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