Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Straitscom — 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) |
|---|---|---|---|---|---|
| K910009 | HYPOALLERGENIC LATEX EXAMINATION GLOVES | Straitscom | 1991-01-24 | 22 | 0 |
| K903534 | SURGEON'S (SURGICAL) GLOVES | Straitscom | 1990-08-17 | 11 | 0 |
| K885319 | NON-STERILE EXAM GLOVES | Straitscom | 1989-09-13 | 258 | 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