FDA 510(k)

藍色橡膠檢查無粉手套

K 號：K192329 · 2019-11-25

申請人Jr Engineering & Medical Technologies (M) Sdn. Bhd.

決定日期2019-11-25

產品代碼LYY

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.