FDA 510(k)

コーンフラワー・ブルー・ポリフェリー・フリー・ニトリル・検査手袋がん化学療法薬およびフェンタニルシチラートとの使用を試験済み

K番号: K232764 · 2024-02-07

決定日2024-02-07

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Substantially Equivalent

医療機器の概要

Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Eco Medi Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2024-02-07 under 510(k) number K232764. 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 Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2024-02-07. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K232764.

When did Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate receive FDA 510(k) clearance?

Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2024-02-07, under 510(k) number K232764.

Who is the listed applicant for Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA 510(k) record lists Eco Medi Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is LZA.

申請者としてEco Medi Glove Sdn. Bhd.を記載するその他の記録

K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid K233405ブルー・プルーフリー・ニトリル・検査手袋が化疗薬およびフェンタニル検査を主張 K220943ダブルカラーのブルー/ホワイトポリウレタンフリーのニトリル検査手袋で、化学療法薬およびフェンタニルテストを主張 K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein K193121GEN 2 ニトリル検査手袋（青色）で皮膚炎の可能性が低いと主張し、化学療法薬との使用をテスト済みとする主張付き K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims

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