FDA 510(k)

ハリヤードパープルニトリルマックスパウダーフリーエクスアムグローブ化学療法薬との使用に適しています

K番号: K182096 · 2018-11-02

決定日2018-11-02

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Substantially Equivalent

医療機器の概要

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Owens & Minor Halyard, Inc.. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K182096. 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 Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs?

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Owens & Minor Halyard, Inc.. The 510(k) number is K182096.

When did Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-11-02, under 510(k) number K182096.

Who is the listed applicant for Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Owens & Minor Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs?

The FDA product code for Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs is LZA.

申請者としてOwens & Minor Halyard, Inc.を記載するその他の記録

K181959HALYARD ソートスマート* 消毒包装（H450、H650）

公式ソース

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