Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synmertex Co, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
49 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032190 | DISPOSABLE POWDERED VINYL EXAM GLOVES | Synmertex Co, Ltd. | 2003-08-14 | 28 | 0 |
| K032172 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES | Synmertex Co, Ltd. | 2003-08-14 | 29 | 0 |
| K031120 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES | Synmertex Co, Ltd. | 2003-05-23 | 45 | 0 |
| K031076 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COL | Synmertex Co, Ltd. | 2003-05-23 | 49 | 0 |
| K031171 | DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES | Synmertex Co, Ltd. | 2003-05-23 | 39 | 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