FDA 510(k)

粉体不使用ニトリル患者検査手袋、青色、非無菌、粉体不使用ニトリル患者検査手袋、白色、非無菌

K番号: K151750 · 2016-08-03

決定日2016-08-03

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

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Kossan International Sdn Bhd. It received FDA 510(k) clearance on 2016-08-03 under 510(k) number K151750. 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 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile?

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile is a medical device that received FDA 510(k) clearance on 2016-08-03. The listed applicant is Kossan International Sdn Bhd. The 510(k) number is K151750.

When did Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile receive FDA 510(k) clearance?

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile received FDA 510(k) clearance on 2016-08-03, under 510(k) number K151750.

Who is the listed applicant for Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile?

FDA 510(k)レコードには、Kossan International Sdn Bhdが申請者として記載されています。これは、そのままにして装置製造業者を確定することはできません。

What is the FDA product code for Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile?

The FDA product code for Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile is LZA.