Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wells Lamont Corp. — 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) |
|---|---|---|---|---|---|
| K944763 | CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE L | Wells Lamont Corp. | 1995-04-10 | 195 | 0 |
| K940274 | NYLON LINER GLOVES | Wells Lamont Corp. | 1994-05-12 | 111 | 0 |
| K925937 | WELLS LAMONT HANDAGES/MED WRAP DRESSINGS | Wells Lamont Corp. | 1993-08-09 | 258 | 0 |
| K922407 | WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS | Wells Lamont Corp. | 1993-06-15 | 390 | 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