# GFA Production Xiamen Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For GFA Production Xiamen 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 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 2026-09-16.

- **Firm:** GFA Production Xiamen 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:** Huli Industrial Park No. 20 , Meixi Street; Tongan , Xiamen, Fujian CHINA _(verified: appears in the quote below)_
- **Date published:** 11/07/2024 _(verified: appears in the quote below)_
- **Product code:** 80 L - - ZA Glove, Patient Examination, Poly | 80 O - - IG Rubber examination gloves, powder-free _(verified: each item appears in the quote below)_
- **Product:** Nitrile Gloves | Nitrile Gloves _(verified: each item appears in the quote below)_

## 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 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:

## 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/).