FDA 510(k)

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid

K番号: K233560 · 2024-02-26

決定日2024-02-26

製品コードLZA

諮問委員会HO

決定Substantially Equivalent

医療機器の概要

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid 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 2024-02-26 under 510(k) number K233560. 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 Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid?

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K233560.

When did Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid receive FDA 510(k) clearance?

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid received FDA 510(k) clearance on 2024-02-26, under 510(k) number K233560.

Who is the listed applicant for Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid?

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 Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid?

The FDA product code for Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid is LZA.

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

K232764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 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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