Syntex Healthcare Products Co., Ltd. · 89-08 · CHINA
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
- 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 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:
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html