FDA 510(k)

星宇粉体不含有害物质のナイロン患者検査手袋、青色

K番号: K171616 · 2017-07-20

決定日2017-07-20

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

Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Xingyu Gloves Co., Ltd.. It received FDA 510(k) clearance on 2017-07-20 under 510(k) number K171616. 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 Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color?

Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color is a medical device that received FDA 510(k) clearance on 2017-07-20. The listed applicant is Shandong Xingyu Gloves Co., Ltd.. The 510(k) number is K171616.

When did Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color receive FDA 510(k) clearance?

Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color received FDA 510(k) clearance on 2017-07-20, under 510(k) number K171616.

Who is the listed applicant for Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color?

The FDA 510(k) record lists Shandong Xingyu Gloves Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color?

The FDA product code for Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color is LZA.

申請者としてShandong Xingyu Gloves Co., Ltd.を記載するその他の記録

K233990ニトリル使い捨て検査手袋、化学療法薬およびフェンタニル（D5000）との使用試験済み K221272医療用フェイスマスク K171615星宇ニトリル粉体不使用患者検査手袋、白色

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