Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Syntex Healthcare Products Co., Ltd. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
95 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use | Syntex Healthcare Products Co., Ltd. | 2024-04-02 | 82 | 0 |
| K231643 | Biodegradable Nitrile Powder Free Examination Gloves Tested | Syntex Healthcare Products Co., Ltd. | 2023-09-08 | 95 | 0 |
| K103770 | SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL | Syntex Healthcare Products Co., Ltd. | 2011-04-21 | 115 | 0 |
| K102096 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | Syntex Healthcare Products Co., Ltd. | 2010-10-04 | 69 | 0 |
| K052877 | POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE | Syntex Healthcare Products Co., Ltd. | 2005-11-08 | 27 | 0 |
| K042226 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHE | Syntex Healthcare Products Co., Ltd. | 2004-09-30 | 44 | 0 |
| K033777 | ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | Syntex Healthcare Products Co., Ltd. | 2004-02-05 | 63 | 0 |
| K023826 | SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR | Syntex Healthcare Products Co., Ltd. | 2003-01-24 | 67 | 0 |
| K022784 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR | Syntex Healthcare Products Co., Ltd. | 2002-11-13 | 83 | 0 |
| K022088 | SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE | Syntex Healthcare Products Co., Ltd. | 2002-09-03 | 68 | 0 |
| K022090 | SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE | Syntex Healthcare Products Co., Ltd. | 2002-09-03 | 68 | 0 |
| K022092 | SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE | Syntex Healthcare Products Co., Ltd. | 2002-09-03 | 68 | 0 |
| K022146 | SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE | Syntex Healthcare Products Co., Ltd. | 2002-09-03 | 63 | 0 |
| K021058 | SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH L | Syntex Healthcare Products Co., Ltd. | 2002-05-14 | 42 | 0 |
| K021059 | SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN | Syntex Healthcare Products Co., Ltd. | 2002-05-14 | 42 | 0 |
| K020751 | SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE | Syntex Healthcare Products Co., Ltd. | 2002-05-02 | 56 | 0 |
| K020493 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE | Syntex Healthcare Products Co., Ltd. | 2002-02-26 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda