# Abound Texfactory · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 38 Xinmin 4 Jie , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 03/08/2013 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** Nocturns Anti-Glare Glasses | Nocturns Anti-Glare Glasses | Nocturns Anti-Glare Glasses _(verified: each item appears in the quote below)_
- **FDA notes:** class II | Class II | class II _(verified: each item appears in the quote below)_

## 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

## 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

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).