Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ug Healthcare (Usa), 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) |
|---|---|---|---|---|---|
| K112005 | NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WIT | Ug Healthcare (Usa), Inc. | 2012-03-21 | 252 | 0 |
| K112012 | NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES | Ug Healthcare (Usa), Inc. | 2012-03-21 | 252 | 0 |
| K062688 | POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABEL | Ug Healthcare (Usa), Inc. | 2006-11-30 | 83 | 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