Syntex Healthcare Products Co., Ltd. · 89-08 · CHINA
For Syntex Healthcare Products 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 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 2026-09-30.
- Firm
- Syntex Healthcare 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. 1 Fangjiazhuang , Xinji City , Industrial Zone, Hebei Province CHINA verified
- Date published
- 02/23/2024 verified
- Product code
- 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty each item verified
- 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 each item verified
What the source says
Syntex Healthcare Products Co., Ltd. Date Published : 02/23/2024 No. 1 Fangjiazhuang , Xinji City , Industrial Zone, Hebei Province 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: 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:
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html