ZHEJIANG XICHEN MEDICAL TECHNOLOGY CO LTD · 89-08 · CHINA

For ZHEJIANG XICHEN MEDICAL TECHNOLOGY CO LTD, import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is KN95 Face Mask | Sterile Surgical Mask | Medical Face Mask | KN95 Face Mask | Sterile Surgical Mask | Medical Face Mask | KN95 Face Mask; product code is 80 F - - XX Mask, Surgical | 80 F - - XX Mask, Surgical | 80 F - - XX Mask, Surgical | 80 M - - SH Respirator, surgical | 80 M - - SH Respirator, surgical | 80 M - - SH Respirator, surgical | 80 N - - ZJ Respirator, n95, home use; date published is 03/16/2022; address is F/2 , 3 Bldg, 6 Lvyuan Rd , Zhou, Zhejiang CHINA, verified against its source on 2026-09-30.

What the source says

ZHEJIANG XICHEN MEDICAL TECHNOLOGY CO LTD Date Published : 03/16/2022 F/2 , 3 Bldg, 6 Lvyuan Rd , Zhou, Zhejiang CHINA

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.