Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neo-Sigma, 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) |
|---|---|---|---|---|---|
| K891841 | LATEX EXAM GLOVES (MFG. YEOU JIH INDUSTRIAL CO.) | Neo-Sigma, Inc. | 1989-05-31 | 64 | 0 |
| K891567 | VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.) | Neo-Sigma, Inc. | 1989-04-11 | 25 | 0 |
| K891566 | VINYL EXAM GLOVES (MFG. AM GLOVES CO. LTD.) | Neo-Sigma, Inc. | 1989-04-11 | 25 | 0 |
| K891568 | VINYL EXAM GLOVES (MFG. JM GLOVES CO. LTD.) | Neo-Sigma, Inc. | 1989-04-11 | 25 | 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