FDA 510(k)

GEN 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

K番号: K193121 · 2020-03-20

決定日2020-03-20

製品コードLZA

諮問委員会HO

決定Substantially Equivalent

医療機器の概要

GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential 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 2020-03-20 under 510(k) number K193121. 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 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims?

GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Eco Medi Glove Sdn. Bhd.. The 510(k) number is K193121.

When did GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims receive FDA 510(k) clearance?

GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193121.

Who is the listed applicant for GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential 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 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims?

The FDA product code for GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims is LZA.