Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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