ZHEJIANG XICHEN MEDICAL TECHNOLOGY CO LTD · 89-08 · CHINA
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
- 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
- Address
- F/2 , 3 Bldg, 6 Lvyuan Rd , Zhou, Zhejiang CHINA verified
- Date published
- 03/16/2022 verified
- 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 each item verified
- Product
- Sterile Surgical Mask | KN95 Face Mask | Medical Face Mask | Medical Face Mask | Sterile Surgical Mask | KN95 Face Mask | KN95 Face Mask each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html