Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Foodhandler, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892575 | VINYL PATIENT EXAMINATION GLOVES | Foodhandler, Inc. | 1989-07-24 | 105 | 0 |
| K892566 | PATIENT EXAMINATION GLOVES (LATEX) | Foodhandler, Inc. | 1989-06-23 | 74 | 0 |
| K892480 | PATIENT EXAMINATION GLOVES | Foodhandler, Inc. | 1989-06-21 | 75 | 0 |
| K892752 | PATIENT EXAM GLOVES (MFG. WOOD TING INDUSTRY) | Foodhandler, Inc. | 1989-06-06 | 56 | 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