FDA 510(k)

無粉体ブルーニトリル検査手袋 32種類の化学療法薬およびフェンタニルシチラートとの使用試験済み

K番号: K183354 · 2019-06-20

決定日2019-06-20

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

Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Gx Corporation Sdn Bhd. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K183354. 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 Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate?

Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Gx Corporation Sdn Bhd. The 510(k) number is K183354.

When did Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate receive FDA 510(k) clearance?

Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2019-06-20, under 510(k) number K183354.

Who is the listed applicant for Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate?

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

What is the FDA product code for Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate is LZA.

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

K200915無粉白色ポリイソプレーン手術手袋-化学療法薬との使用試験済

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