FDA 510(k)

ハリヤードラベンダー、低皮膚炎リスク、粉なし検査手袋、化学療法薬およびフェンタニルシチル酸との使用試験済み

K番号: K202622 · 2021-01-07

決定日2021-01-07

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

Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2021-01-07 under 510(k) number K202622. 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 Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate?

Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2021-01-07. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K202622.

When did Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate receive FDA 510(k) clearance?

Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate received FDA 510(k) clearance on 2021-01-07, under 510(k) number K202622.

Who is the listed applicant for Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate?

FDA 510(k)レコードでは、O&M Halyard, Inc.が申請者として記載されています。これは、その単独で装置製造業者であることを証明するものではありません。

What is the FDA product code for Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate?

The FDA product code for Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate is LZA.