Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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