FDA 510(k)

Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims

K番号: K181066 · 2018-09-26

決定日2018-09-26

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

Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims 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 2018-09-26 under 510(k) number K181066. 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 claim and with tested for Use with Chemotherapy Drugs Claims?

Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K181066.

When did Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims receive FDA 510(k) clearance?

Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims received FDA 510(k) clearance on 2018-09-26, under 510(k) number K181066.

Who is the listed applicant for Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims?

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 claim and with tested for Use with Chemotherapy Drugs Claims?

The FDA product code for Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims 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 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

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