FDA 510(k)

Blue Latex检查手套，无粉

K号: K192329 · 2019-11-25

申请人Jr Engineering & Medical Technologies (M) Sdn. Bhd.

决定日期2019-11-25

产品代码LYY

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

Blue Latex Examination Powder Free Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2019-11-25 under 510(k) number K192329. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Blue Latex Examination Powder Free Gloves?

Blue Latex Examination Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2019-11-25. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K192329.

When did Blue Latex Examination Powder Free Gloves receive FDA 510(k) clearance?

Blue Latex Examination Powder Free Gloves received FDA 510(k) clearance on 2019-11-25, under 510(k) number K192329.

Who is the listed applicant for Blue Latex Examination Powder Free Gloves?

The FDA 510(k) record lists Jr Engineering & Medical Technologies (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Latex Examination Powder Free Gloves?

The FDA product code for Blue Latex Examination Powder Free Gloves is LYY.