Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oon Corp. Resources · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
189 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103650 | NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WIT | Oon Corp. Resources | 2011-03-23 | 99 | 0 |
| K093496 | NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH | Oon Corp. Resources | 2010-02-03 | 85 | 0 |
| K002448 | LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS | Oon Corp. Resources | 2000-09-11 | 33 | 0 |
| K981917 | POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROT | Oon Corp. Resources | 1998-12-07 | 189 | 0 |
| K970770 | LATEX EXAMINATION GLOVES | Oon Corp. Resources | 1997-07-14 | 133 | 0 |
| K891511 | PATIENT EXAMINATION GLOVES (LATEX) | Oon Corp. Resources | 1989-03-29 | 13 | 0 |
| K891424 | PATIENT EXAMINATION GLOVES (LATEX) | Oon Corp. Resources | 1989-03-24 | 10 | 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