FDA 510(k)

可生物降解無粉乳膠檢查手套，自然色、藍色、黑色和綠色，並標示蛋白質含量聲明（50微克或以下）

K 號：K211620 · 2021-08-19

決定日期2021-08-19

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

Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) 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 2021-08-19 under 510(k) number K211620. 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 Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)?

Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K211620.

When did Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) receive FDA 510(k) clearance?

Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) received FDA 510(k) clearance on 2021-08-19, under 510(k) number K211620.

Who is the listed applicant for Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)?

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 Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)?

The FDA product code for Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) is LYY.