Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Emerson & Co. Srl — 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) |
|---|---|---|---|---|---|
| K192933 | Polyisoprene Powder Free, Black Colour Surgical Gloves | Emerson & Co. Srl | 2021-01-13 | 454 | 0 |
| K151228 | PROGUARD Polyisoprene Powder Free, Black Colour Surgical Glo | Emerson & Co. Srl | 2016-01-15 | 253 | 0 |
| K982832 | PROGUARD, RR-1, RR-2 | Emerson & Co. Srl | 1998-12-23 | 133 | 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