FDA 510(k)

無菌ノイズフリーニトリル検査手袋、青色。化学療法薬との使用に適したテスト済み、非発熱性ラベル記載を主張

K番号: K160467 · 2016-08-02

決定日2016-08-02

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

Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim 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 2016-08-02 under 510(k) number K160467. 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 Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim?

Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a medical device that received FDA 510(k) clearance on 2016-08-02. The listed applicant is Kossan International Sdn Bhd. The 510(k) number is K160467.

When did Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim receive FDA 510(k) clearance?

Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim received FDA 510(k) clearance on 2016-08-02, under 510(k) number K160467.

Who is the listed applicant for Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim?

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 Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim?

The FDA product code for Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is LZA.