GFA Production Xiamen Co., Ltd. · 89-08 · CHINA
For GFA Production Xiamen 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 Nitrile Gloves | Nitrile Gloves; product code is 80 L - - ZA Glove, Patient Examination, Poly | 80 O - - IG Rubber examination gloves, powder-free; date published is 11/07/2024; address is Huli Industrial Park No. 20 , Meixi Street; Tongan , Xiamen, Fujian CHINA, verified against its source on 2026-09-30.
- Firm
- GFA Production Xiamen 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
- Huli Industrial Park No. 20 , Meixi Street; Tongan , Xiamen, Fujian CHINA verified
- Date published
- 11/07/2024 verified
- Product code
- 80 L - - ZA Glove, Patient Examination, Poly | 80 O - - IG Rubber examination gloves, powder-free each item verified
- Product
- Nitrile Gloves | Nitrile Gloves each item verified
What the source says
GFA Production Xiamen Co., Ltd. Date Published : 11/07/2024 Huli Industrial Park No. 20 , Meixi Street; Tongan , Xiamen, Fujian 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 and Product
80 L - - ZA Glove, Patient Examination, Poly Date Published: 11/07/2024 Desc: Nitrile Gloves Notes: 80 O - - IG Rubber examination gloves, powder-free Date Published: 11/07/2024 Desc: Nitrile Gloves Notes:
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html