Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Health Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
246 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974356 | SURGEON'S GLOVES | American Health Products, Inc. | 1998-01-29 | 71 | 0 |
| K923967 | PATIENT EXAM GLOVES (POWDER FREE) | American Health Products, Inc. | 1992-12-15 | 131 | 0 |
| K892291 | PATIENT EXAM GLOVES (MFG. AMERICAN RUBBER PRODUCT) | American Health Products, Inc. | 1989-05-11 | 35 | 0 |
| K892292 | PATIENT EXAM GLOVES (MFG. MULTI-COM SDN BHD) | American Health Products, Inc. | 1989-04-28 | 22 | 0 |
| K874148 | MONITRON SYSTEM | American Health Products, Inc. | 1988-06-15 | 246 | 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