Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Copioumed Intl., Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
293 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030927 | POWDERED VINYL EXAM GLOVES, WHITE | Copioumed Intl., Inc. | 2003-04-17 | 24 | 0 |
| K021961 | POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE | Copioumed Intl., Inc. | 2002-07-02 | 18 | 0 |
| K021743 | (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: | Copioumed Intl., Inc. | 2002-06-10 | 13 | 0 |
| K972624 | POLY (VINYL) EXAM GLOVE, POWDER-FREE | Copioumed Intl., Inc. | 1997-11-06 | 115 | 0 |
| K971316 | POLY (VINYL) EXAM GLOVE, POWDERED | Copioumed Intl., Inc. | 1997-08-27 | 140 | 0 |
| K965237 | NURSES BOUFFANT CAP | Copioumed Intl., Inc. | 1997-08-27 | 239 | 0 |
| K961342 | SHOE COVER, NON-STERILE | Copioumed Intl., Inc. | 1996-12-30 | 285 | 0 |
| K960999 | ISOLATION GOWN | Copioumed Intl., Inc. | 1996-12-30 | 293 | 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