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

For Syntex Healthcare 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 Powder-Free Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs | Powder-Free Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs; product code is 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty; date published is 02/23/2024; address is No. 1 Fangjiazhuang , Xinji City , Industrial Zone, Hebei Province CHINA, verified against its source on 2026-09-16.

- **Firm:** Syntex Healthcare Products 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:** No. 1 Fangjiazhuang , Xinji City , Industrial Zone, Hebei Province CHINA _(verified: appears in the quote below)_
- **Date published:** 02/23/2024 _(verified: appears in the quote below)_
- **Product code:** 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty _(verified: each item appears in the quote below)_
- **Product:** Powder-Free Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs | Powder-Free Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs _(verified: each item appears in the quote below)_

## What the source says

> Syntex Healthcare Products Co., Ltd. Date Published : 02/23/2024 No. 1 Fangjiazhuang , Xinji City , Industrial Zone, Hebei Province CHINA 80 L - - ZA Glove, Patient Examination, Poly Date Published: 02/23/2024 Desc: Powder-Free Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs Notes: 80 L - - ZC Glove, Patient Examination, Specialty Date Published: 02/23/2024 Desc: Powder-Free Nitrile Examination Gloves (Blue) Tested for use with Chemotherapy Drugs 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/).