Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Semperit Technische Produkte Gesellshaft — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013560 | SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 | Semperit Technische Produkte Gesellshaft | 2002-01-16 | 82 | 0 |
| K012819 | SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 | Semperit Technische Produkte Gesellshaft | 2001-11-16 | 85 | 0 |
| K981096 | SEMPERMED SURGEONS' GLOVES - SUPREME | Semperit Technische Produkte Gesellshaft | 1998-10-29 | 218 | 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