Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lowenkamp Intl., 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) |
|---|---|---|---|---|---|
| K951940 | PATIENT EXAMINATION GLOVE | Lowenkamp Intl., Inc. | 1995-06-28 | 64 | 0 |
| K946154 | MALA LATEX EXAM GLOVES AND SCAN-SUB | Lowenkamp Intl., Inc. | 1995-01-11 | 26 | 0 |
| K910439 | FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM) | Lowenkamp Intl., Inc. | 1991-02-25 | 25 | 0 |
| K903513 | SANOFLEX-STERILE LATEX SURGICAL GLOVES | Lowenkamp Intl., Inc. | 1990-09-14 | 42 | 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