FDA 510(k)

バイオデグレード可能なノイチル検査手袋、ブルー-ホワイトカラー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

K番号: K202083 · 2021-03-25

決定日2021-03-25

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

Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K202083. 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 Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs?

Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K202083.

When did Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2021-03-25, under 510(k) number K202083.

Who is the listed applicant for Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs?

The FDA product code for Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs is LZA.