Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Evergrade Healthcare Products Sdn Bhd · 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) |
|---|---|---|---|---|---|
| K973664 | LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LAB | Evergrade Healthcare Products Sdn Bhd | 1998-03-13 | 169 | 0 |
| K942855 | NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES | Evergrade Healthcare Products Sdn Bhd | 1995-11-15 | 517 | 0 |
| K932116 | PATIENT EXAMINATION GLOVES (POWDER FREE) | Evergrade Healthcare Products Sdn Bhd | 1994-03-15 | 316 | 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