Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Full Synergy Medical Products, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
85 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113749 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALO | Full Synergy Medical Products, Inc. | 2012-03-15 | 85 | 0 |
| K113790 | DISPOSABLE VINYL EXAM GLOVE, POWDERED | Full Synergy Medical Products, Inc. | 2012-03-06 | 74 | 0 |
| K113750 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR | Full Synergy Medical Products, Inc. | 2012-03-05 | 75 | 0 |
| K113797 | DISPOSABLE VINYL EXAM GLOVE, POWDER FREE | Full Synergy Medical Products, Inc. | 2012-03-02 | 70 | 0 |
| K113710 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR | Full Synergy Medical Products, Inc. | 2012-02-14 | 57 | 0 |
| K113722 | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR | Full Synergy Medical Products, Inc. | 2012-02-14 | 57 | 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