FDA 510(k)

奈爾烯檢查手套，粉紅色；奈爾烯檢查手套，黑色；奈爾烯檢查手套，白色

K 號：K221887 · 2022-09-24

申請人Guangdong Kingfa Sci. & Tech.Co., Ltd.

決定日期2022-09-24

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

Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2022-09-24 under 510(k) number K221887. 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 Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color?

Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color is a medical device that received FDA 510(k) clearance on 2022-09-24. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K221887.

When did Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color receive FDA 510(k) clearance?

Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color received FDA 510(k) clearance on 2022-09-24, under 510(k) number K221887.

Who is the listed applicant for Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color?

The FDA 510(k) record lists Guangdong Kingfa Sci. & Tech.Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color?

The FDA product code for Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color is LZA.