Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Phoenix Glove Co. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
70 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K830660 | STERILE SURGICAL DRAPES | Phoenix Glove Co. | 1983-03-17 | 15 | 0 |
| K821044 | PATIENT PREP KITS/TRAYS-STERILE | Phoenix Glove Co. | 1982-06-23 | 70 | 0 |
| K821666 | STERILE SURGICAL DRAPES | Phoenix Glove Co. | 1982-06-21 | 14 | 0 |
| K821043 | STERILE PATIENT EXAM. GLOVES | Phoenix Glove Co. | 1982-05-21 | 37 | 0 |
| K801846 | ELECTROCARDIOGRAPH ELECTRODE | Phoenix Glove Co. | 1980-09-09 | 36 | 0 |
| K781820 | GLOVES, VINYL EXAMINATION | Phoenix Glove Co. | 1978-12-07 | 41 | 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