Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Associated Ent., 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) |
|---|---|---|---|---|---|
| K924837 | DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET | Associated Ent., Inc. | 1993-10-12 | 382 | 0 |
| K915636 | GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. | Associated Ent., Inc. | 1992-07-13 | 209 | 0 |
| K891835 | BUD BRAND PATIENT EXAMINATION GLOVES (VINYL) | Associated Ent., Inc. | 1989-06-22 | 87 | 0 |
| K891836 | BUD BRAND PATIENT EXAMINATION GLOVES (LATEX) | Associated Ent., Inc. | 1989-05-12 | 46 | 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