FDA 510(k)

粉体不使用ニトリル検査手袋、青色、化学療法薬との使用試験済

K番号: K171782 · 2017-10-12

決定日2017-10-12

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 Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sail Medical Co.,Ltd. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K171782. 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 Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs?

Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Blue Sail Medical Co.,Ltd. The 510(k) number is K171782.

When did Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs received FDA 510(k) clearance on 2017-10-12, under 510(k) number K171782.

Who is the listed applicant for Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs?

The FDA 510(k) record lists Blue Sail Medical Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs?

The FDA product code for Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs is LZA.

申請者としてBlue Sail Medical Co.,Ltdを記載するその他の記録

K163126粉体不使用ニトリル検査手袋（青色、白色、黑色、紫青色、コバルト青色）

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