FDA 510(k)

犀牛健康非无菌、無粉乳膠檢查手套

K 號：K203236 · 2021-08-16

決定日期2021-08-16

產品代碼LZA

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

Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove is the device name listed in this FDA 510(k) record. The listed applicant is Rhino Health, Inc.. It received FDA 510(k) clearance on 2021-08-16 under 510(k) number K203236. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove?

Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Rhino Health, Inc.. The 510(k) number is K203236.

When did Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove receive FDA 510(k) clearance?

Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove received FDA 510(k) clearance on 2021-08-16, under 510(k) number K203236.

Who is the listed applicant for Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove?

The FDA 510(k) record lists Rhino Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove?

The FDA product code for Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove is LZA.

其他以 Rhino Health, Inc. 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。

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相關器械（代碼：LZA）

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。

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官方來源

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