# DONGGUAN ZHANHUI PLASTIC TECHNOLOGY Co Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For DONGGUAN ZHANHUI PLASTIC 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 N95 Protective Mask | N95 Protective Mask | N95 Protective Mask | N95 Protective Mask; product code is 80 F - - XX Mask, Surgical | 80 L - - YU Accessory, Surgical Apparel | 80 M - - SH Respirator, surgical | 80 N - - ZJ Respirator, n95, home use; date published is 03/07/2022; address is No. 66 S 5th St , Dongguan, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** DONGGUAN ZHANHUI PLASTIC 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:** No. 66 S 5th St , Dongguan, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 03/07/2022 _(verified: appears in the quote below)_
- **Product code:** 80 F - - XX Mask, Surgical | 80 L - - YU Accessory, Surgical Apparel | 80 M - - SH Respirator, surgical | 80 N - - ZJ Respirator, n95, home use _(verified: each item appears in the quote below)_
- **Product:** N95 Protective Mask | N95 Protective Mask | N95 Protective Mask | N95 Protective Mask _(verified: each item appears in the quote below)_

## What the source says

> DONGGUAN ZHANHUI PLASTIC TECHNOLOGY Co Ltd Date Published : 03/07/2022 No. 66 S 5th St , Dongguan, Guangdong CHINA 80 F - - XX Mask, Surgical Date Published: 03/07/2022 Desc: N95 Protective Mask 80 L - - YU Accessory, Surgical Apparel Date Published: 03/07/2022 Desc: N95 Protective Mask 80 M - - SH Respirator, surgical Date Published: 03/07/2022 Desc: N95 Protective Mask 80 N - - ZJ Respirator, n95, home use Date Published: 03/07/2022 Desc: N95 Protective 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/).