Abound Texfactory · 89-08 · CHINA
For Abound Texfactory, 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 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 listed twice: 38 Xinmin 4 Jie , Guangzhou, Guangdong CHINA and G F 5th Bldg Metal , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-30.
- 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
- G F 5th Bldg Metal , Guangzhou, Guangdong CHINA also listed
- 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
— 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, Product and FDA notes
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
— all from 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
— accessdata.fda.gov, retrieved 2026-09-15
Product code
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
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html