FDA 510(k)

無塩素ラテックス患者検査手袋、黒色、非無菌、タンパク質含有量表示（手袋あたり1平方デシメートルにつき50μg以下の総抽出可能タンパク質含有）

K番号: K230573 · 2023-06-13

決定日2023-06-13

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]

決定大幅同等

医療機器の概要

Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) is the device name listed in this FDA 510(k) record. The listed applicant is Kossan International Sdn Bhd. It received FDA 510(k) clearance on 2023-06-13 under 510(k) number K230573. 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 Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)?

Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) is a medical device that received FDA 510(k) clearance on 2023-06-13. The listed applicant is Kossan International Sdn Bhd. The 510(k) number is K230573.

When did Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) receive FDA 510(k) clearance?

Who is the listed applicant for Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)?

FDA 510(k)レコードには、Kossan International Sdn Bhdが申請者として記載されています。これは、そのままにして装置製造業者を確定することはできません。

What is the FDA product code for Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)?

The FDA product code for Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) is LYY.

申請者としてKossan International Sdn Bhdを記載するその他の記録

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