FDA 510(k)

ニトリル検査手袋化学療法薬との使用に適した無菌検査済み白色

K番号: K190725 · 2019-12-17

決定日2019-12-17

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 Sterile Tested for use with Chemotherapy Drugs Claim, White is the device name listed in this FDA 510(k) record. The listed applicant is Riverstone Resources Sdn Bhd. It received FDA 510(k) clearance on 2019-12-17 under 510(k) number K190725. 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 Sterile Tested for use with Chemotherapy Drugs Claim, White?

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White is a medical device that received FDA 510(k) clearance on 2019-12-17. The listed applicant is Riverstone Resources Sdn Bhd. The 510(k) number is K190725.

When did Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White receive FDA 510(k) clearance?

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White received FDA 510(k) clearance on 2019-12-17, under 510(k) number K190725.

Who is the listed applicant for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

The FDA 510(k) record lists Riverstone Resources Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

The FDA product code for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White is LZA.

申請者としてRiverstone Resources Sdn Bhdを記載するその他の記録

K220672ブルー・プルーフ・フリー・ニトリル・検査手袋、葡萄香り付き、化学療法薬およびフェンタニル検査主張 K220401ピンクパウダーフリーのニトリル検査手袋、ガムフレーバー、化学療法薬およびフェンタニル検査主張 K200326粉体不使用ニトリル検査手袋（アクアグリーン）K180452ホワイトニトリル検査手袋、無菌で化学療法薬を使用した主張

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