Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Barriermed, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060733 | SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPR | Barriermed, Inc. | 2006-04-24 | 35 | 0 |
| K011446 | BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOV | Barriermed, Inc. | 2001-06-14 | 34 | 0 |
| K890974 | PATIENT EXAMINATION GLOVE | Barriermed, Inc. | 1989-07-14 | 137 | 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