Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pt. Eka Wira Asia · 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) |
|---|---|---|---|---|---|
| K980729 | NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LA | Pt. Eka Wira Asia | 1998-04-02 | 36 | 0 |
| K980807 | NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LAR | Pt. Eka Wira Asia | 1998-04-02 | 36 | 0 |
| K941056 | LATEX EXAMINATION GLOVES, POWDER FREE | Pt. Eka Wira Asia | 1994-04-29 | 57 | 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