Reference Source

Guangzhou Aillx Rubber Product Co., Ltd · 89-08 · CHINA

For Guangzhou Aillx Rubber Product Co., Ltd, 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 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 2026-09-30.

Firm
Guangzhou Aillx Rubber Product Co., Ltd 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
Jin Lai Mansion, No 799 San Yuan Li Dao , Guangdong, CHINA verified
Date published
08/19/2012 verified
Product code
85 H - - IS Condom | 85 L - - TZ Condom With Nonoxynol-9 each item verified
Product
Condoms | Condoms each item verified
FDA notes
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

Guangzhou Aillx Rubber Product Co., Ltd Date Published : 08/19/2012 Jin Lai Mansion, No 799 San Yuan Li Dao , 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

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

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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