FDA 510(k)

ニトリル検査手袋、ピンク色；ニトリル検査手袋、ブラック色、ニトリル検査手袋、ホワイト色

K番号: K221887 · 2022-09-24

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

決定日2022-09-24

製品コードLZA

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

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.

よくある質問

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.