Syntex Healthcare Products Co., Ltd.
Xinji City, Hebei Province, CN
Syntex Healthcare Products Co., Ltd. appears in FDA device records in Xinji City, Hebei Province, CN. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Syntex Healthcare Products Co., Ltd. between 2002 and 2024. The busiest year on record is 2002, with 9. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 9 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | |
| K231643 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | |
| K103770 | SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL | LZA | Substantially Equivalent | |
| K102096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | |
| K052877 | POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K042226 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY | LZA | Substantially Equivalent | |
| K033777 | ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K023826 | SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR | LYY | Substantially Equivalent | |
| K022784 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR | LZA | Substantially Equivalent | |
| K022146 | SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K022092 | SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K022090 | SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K022088 | SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K021059 | SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM | LYY | Substantially Equivalent | |
| K021058 | SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM | LYY | Substantially Equivalent | |
| K020751 | SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K020493 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain