DONGGUAN ZHANHUI PLASTIC TECHNOLOGY Co Ltd · 89-08 · CHINA
For DONGGUAN ZHANHUI PLASTIC 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 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 2026-09-30.
- Firm
- DONGGUAN ZHANHUI PLASTIC 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
- No. 66 S 5th St , Dongguan, Guangdong CHINA verified
- Date published
- 03/07/2022 verified
- 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 each item verified
- Product
- N95 Protective Mask | N95 Protective Mask | N95 Protective Mask | N95 Protective Mask each item verified
What the source says
DONGGUAN ZHANHUI PLASTIC TECHNOLOGY Co Ltd Date Published : 03/07/2022 No. 66 S 5th St , Dongguan, Guangdong CHINA
— accessdata.fda.gov, retrieved 2026-09-15
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.
Product code and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html