FDA 510(k)

ニトリル患者検査手袋、粉なし、青色

K番号: K143477 · 2016-04-14

決定日2016-04-14

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 Patient Examination gloves, Powderfree, Blue color is the device name listed in this FDA 510(k) record. The listed applicant is Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2016-04-14 under 510(k) number K143477. 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 Patient Examination gloves, Powderfree, Blue color?

Nitrile Patient Examination gloves, Powderfree, Blue color is a medical device that received FDA 510(k) clearance on 2016-04-14. The listed applicant is Primus Gloves Pvt Limited. The 510(k) number is K143477.

When did Nitrile Patient Examination gloves, Powderfree, Blue color receive FDA 510(k) clearance?

Nitrile Patient Examination gloves, Powderfree, Blue color received FDA 510(k) clearance on 2016-04-14, under 510(k) number K143477.

Who is the listed applicant for Nitrile Patient Examination gloves, Powderfree, Blue color?

The FDA 510(k) record lists Primus Gloves Pvt Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Patient Examination gloves, Powderfree, Blue color?

The FDA product code for Nitrile Patient Examination gloves, Powderfree, Blue color is LZA.

申請者としてPrimus Gloves Pvt Limitedを記載するその他の記録

K170612無菌ビニル検査手袋、粉無し K170515無菌ニトリル手術手袋、粉体不使用

公式ソース

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