Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Barriermed Glove Co. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
210 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053406 | BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL | Barriermed Glove Co. | 2006-07-05 | 210 | 0 |
| K061038 | BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE S | Barriermed Glove Co. | 2006-06-23 | 70 | 0 |
| K052772 | BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE OR | Barriermed Glove Co. | 2005-12-20 | 78 | 0 |
| K052892 | SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GL | Barriermed Glove Co. | 2005-11-30 | 47 | 0 |
| K990710 | BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES | Barriermed Glove Co. | 1999-05-20 | 77 | 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