# Guangzhou Aillx Rubber Product Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Guangzhou Aillx Rubber Product Co., Ltd · 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 Condoms | Condoms; product code is 85 H - - IS Condom | 85 L - - TZ Condom With Nonoxynol-9; date published is 08/19/2012; address is Jin Lai Mansion, No 799 San Yuan Li Dao , Guangdong, CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou Aillx Rubber Product Co., Ltd _(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:** Jin Lai Mansion, No 799 San Yuan Li Dao , Guangdong, CHINA _(verified: appears in the quote below)_
- **Date published:** 08/19/2012 _(verified: appears in the quote below)_
- **Product code:** 85 H - - IS Condom | 85 L - - TZ Condom With Nonoxynol-9 _(verified: each item appears in the quote below)_
- **Product:** Condoms | Condoms _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Guangzhou Aillx Rubber Product Co., Ltd Date Published : 08/19/2012 Jin Lai Mansion, No 799 San Yuan Li Dao , Guangdong, CHINA 85 H - - IS Condom Date Published: 08/19/2012 Desc: Condoms Notes: Class II 85 L - - TZ Condom With Nonoxynol-9 Date Published: 08/19/2012 Desc: Condoms 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/).