FDA 510(k)

非処理無菌ラテックス検査手袋

K番号: K221667 · 2022-10-28

決定日2022-10-28

製品コードLYY

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Substantially Equivalent

医療機器の概要

Non Sterile Powder Free Latex Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is New Era Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K221667. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Non Sterile Powder Free Latex Examination Glove?

Non Sterile Powder Free Latex Examination Glove is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is New Era Medicare Sdn. Bhd.. The 510(k) number is K221667.

When did Non Sterile Powder Free Latex Examination Glove receive FDA 510(k) clearance?

Non Sterile Powder Free Latex Examination Glove received FDA 510(k) clearance on 2022-10-28, under 510(k) number K221667.

Who is the listed applicant for Non Sterile Powder Free Latex Examination Glove?

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

What is the FDA product code for Non Sterile Powder Free Latex Examination Glove?

The FDA product code for Non Sterile Powder Free Latex Examination Glove is LYY.

申請者としてNew Era Medicare Sdn. Bhd.を記載するその他の記録

K230314Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)K221424Sterile Surgical Powder Free Latex Glove

公式ソース

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