Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Brightsway Holdings 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) |
|---|---|---|---|---|---|
| K992020 | BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) | Brightsway Holdings Sdn Bhd | 1999-07-26 | 40 | 0 |
| K992021 | BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE | Brightsway Holdings Sdn Bhd | 1999-07-23 | 37 | 0 |
| K991750 | BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER F | Brightsway Holdings Sdn Bhd | 1999-06-23 | 30 | 0 |
| K991752 | BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED | Brightsway Holdings Sdn Bhd | 1999-06-23 | 30 | 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