Syntex Healthcare Products Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Cit | April 2, 2024 |
| K231643 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fent | September 8, 2023 |
| K103770 | SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL | April 21, 2011 |
| K102096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | October 4, 2010 |
| K052877 | POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE | November 8, 2005 |
| K042226 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY | September 30, 2004 |
| K033777 | ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | February 5, 2004 |
| K023826 | SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR | January 24, 2003 |
| K022784 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR | November 13, 2002 |
| K022146 | SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE | September 3, 2002 |
| K022090 | SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE | September 3, 2002 |
| K022088 | SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE | September 3, 2002 |
| K022092 | SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE | September 3, 2002 |
| K021059 | SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM | May 14, 2002 |
| K021058 | SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM | May 14, 2002 |
| K020751 | SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE | May 2, 2002 |
| K020493 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE | February 26, 2002 |