FDA 510(k)

粉体不使用ニトリル検査手袋 - 白色、非無菌

K番号: K212802 · 2021-12-02

決定日2021-12-02

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 glove - white, non-sterile is the device name listed in this FDA 510(k) record. The listed applicant is Hong Seng Gloves Sdn Bhd. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K212802. 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 glove - white, non-sterile?

powder free nitrile examination glove - white, non-sterile is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Hong Seng Gloves Sdn Bhd. The 510(k) number is K212802.

When did powder free nitrile examination glove - white, non-sterile receive FDA 510(k) clearance?

powder free nitrile examination glove - white, non-sterile received FDA 510(k) clearance on 2021-12-02, under 510(k) number K212802.

Who is the listed applicant for powder free nitrile examination glove - white, non-sterile?

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

What is the FDA product code for powder free nitrile examination glove - white, non-sterile?

The FDA product code for powder free nitrile examination glove - white, non-sterile is LZA.

申請者としてHong Seng Gloves Sdn Bhdを記載するその他の記録

K221164粉体不使用ニトリル検査手袋 - 蓝色、非無菌、化学療法薬およびフェンタニルとの使用試験済 K212801粉体不使用ニトリル検査手袋-ブラック、非無菌 K212804粉体不使用ニトリル検査手袋-青色、非無菌

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。