FDA 510(k)

GEN 2 氰化物检查手套（蓝色）具有低皮炎潜力声明，并经过化疗药物使用测试声明

K号: K193121 · 2020-03-20

决定日期2020-03-20

产品代码LZA

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.