Abound Texfactory · 89-08 · CHINA
For Abound Texfactory · 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 Nocturns Anti-Glare Glasses | Nocturns Anti-Glare Glasses | Nocturns Anti-Glare Glasses; product code is 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QY Sunglasses (Non-Prescription Including Photosensitive) | 86 N - - JH Lens, Spectacle (Prescription), for Reading Discomfort; date published is 03/08/2013; address is 38 Xinmin 4 Jie , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- Abound Texfactory 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
- 38 Xinmin 4 Jie , Guangzhou, Guangdong CHINA verified
- Date published
- 03/08/2013 verified
- Product code
- 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QY Sunglasses (Non-Prescription Including Photosensitive) | 86 N - - JH Lens, Spectacle (Prescription), for Reading Discomfort each item verified
- Product
- Nocturns Anti-Glare Glasses | Nocturns Anti-Glare Glasses | Nocturns Anti-Glare Glasses each item verified
- FDA notes
- class II | Class II | class II each item verified
What the source says
Abound Texfactory Date Published : 03/08/2013 38 Xinmin 4 Jie , Guangzhou, Guangdong CHINA 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) Date Published: 03/08/2013 Desc: Nocturns Anti-Glare Glasses Notes: class II 86 H - - QY Sunglasses (Non-Prescription Including Photosensitive) Date Published: 03/08/2013 Desc: Nocturns Anti-Glare Glasses Notes: Class II 86 N - - JH Lens, Spectacle (Prescription), for Reading Discomfort Date Published: 03/08/2013 Desc: Nocturns Anti-Glare Glasses Notes: class II
— accessdata.fda.gov, retrieved 2026-09-15
The same source also states
Abound Texfactory Date Published : 03/08/2013 G F 5th Bldg Metal , Guangzhou, Guangdong CHINA 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) Date Published: 03/08/2013 Desc: Nocturns Anti-Glare Glasses Notes: class II 86 H - - QY Sunglasses (Non-Prescription Including Photosensitive) Date Published: 03/08/2013 Desc: Nocturns Anti-Glare Glasses Notes: class II 86 N - - JH Lens, Spectacle (Prescription), for Reading Discomfort Date Published: 03/08/2013 Desc: Nocturns Anti-Glare Glasses Notes: class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html