# ZHEJIANG XICHEN MEDICAL TECHNOLOGY CO LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For ZHEJIANG XICHEN MEDICAL TECHNOLOGY CO LTD · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; product is Sterile Surgical Mask | KN95 Face Mask | Medical Face Mask | Medical Face Mask | Sterile Surgical Mask | KN95 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 2026-09-16.

- **Firm:** ZHEJIANG XICHEN MEDICAL TECHNOLOGY CO LTD _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** F/2 , 3 Bldg, 6 Lvyuan Rd , Zhou, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 03/16/2022 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** Sterile Surgical Mask | KN95 Face Mask | Medical Face Mask | Medical Face Mask | Sterile Surgical Mask | KN95 Face Mask | KN95 Face Mask _(verified: each item appears in the quote below)_

## 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 80 F - - XX Mask, Surgical Date Published: 03/16/2022 Desc: Sterile Surgical Mask 80 F - - XX Mask, Surgical Date Published: 03/16/2022 Desc: KN95 Face Mask 80 F - - XX Mask, Surgical Date Published: 03/16/2022 Desc: Medical Face Mask 80 M - - SH Respirator, surgical Date Published: 03/16/2022 Desc: Medical Face Mask 80 M - - SH Respirator, surgical Date Published: 03/16/2022 Desc: Sterile Surgical Mask 80 M - - SH Respirator, surgical Date Published: 03/16/2022 Desc: KN95 Face Mask 80 N - - ZJ Respirator, n95, home use Date Published: 03/16/2022 Desc: KN95 Face Mask

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).