Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bright Element Sdn Bhd · 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) |
|---|---|---|---|---|---|
| K063776 | ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES | Bright Element Sdn Bhd | 2007-03-02 | 71 | 0 |
| K063777 | ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE | Bright Element Sdn Bhd | 2007-02-23 | 63 | 0 |
| K061074 | ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES | Bright Element Sdn Bhd | 2006-05-24 | 37 | 0 |
| K061078 | BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES | Bright Element Sdn Bhd | 2006-05-19 | 32 | 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