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

For Lucky Board Manufacturing · 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 Surgical Mask; product code is 80 F - - XX Mask, Surgical; date published is 08/30/2013; address is No 34 Pingdi Section, Shen Huei Road , Pingdi Town, Longgong District , Shenzhen, Yandongsheng CHINA, verified against its source on 2026-09-16.

- **Firm:** Lucky Board Manufacturing _(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:** No 34 Pingdi Section, Shen Huei Road , Pingdi Town, Longgong District , Shenzhen, Yandongsheng CHINA _(verified: appears in the quote below)_
- **Date published:** 08/30/2013 _(verified: appears in the quote below)_
- **Product code:** 80 F - - XX Mask, Surgical _(verified: appears in the quote below)_
- **Product:** Surgical Mask _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## What the source says

> Lucky Board Manufacturing Date Published : 08/30/2013 No 34 Pingdi Section, Shen Huei Road , Pingdi Town, Longgong District , Shenzhen, Yandongsheng CHINA 80 F - - XX Mask, Surgical Date Published: 11/08/2018 Desc: Surgical Mask Notes: Class II

## 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/).