DONGGUAN ZHANHUI PLASTIC TECHNOLOGY Co Ltd · 89-08 · CHINA
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
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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