Reference Source

Zhangjiagang Fengyuan Plastic Products Co., Ltd. · 89-08 · CHINA

For Zhangjiagang Fengyuan Plastic Products 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 Patient Examination Gloves; product code is 80 L - - ZA Glove, Patient Examination, Poly; date published is 02/23/2024; address is No. 333, Fumin Middle Road , Tangqiao town , Zhangjiagang City,, Jiangsu CHINA, verified against its source on 2026-09-16.

Firm
Zhangjiagang Fengyuan Plastic Products 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
No. 333, Fumin Middle Road , Tangqiao town , Zhangjiagang City,, Jiangsu CHINA verified
Date published
02/23/2024 verified
Product code
80 L - - ZA Glove, Patient Examination, Poly verified
Product
Nitrile Patient Examination Gloves verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Zhangjiagang Fengyuan Plastic Products Co., Ltd. Date Published : 02/23/2024 No. 333, Fumin Middle Road , Tangqiao town , Zhangjiagang City,, Jiangsu CHINA 80 L - - ZA Glove, Patient Examination, Poly Date Published: 02/23/2024 Desc: Nitrile Patient Examination Gloves Notes:

accessdata.fda.gov, retrieved 2026-09-15

Source

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