Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Brilliant Ray Intl., Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
56 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892022 | PATIENT EXAM GLOVES (MFG. YU HUA LATEX FACTORY) | Brilliant Ray Intl., Inc. | 1989-05-25 | 56 | 0 |
| K892023 | PATIENT EXAM GLOVES (MFG. XIAN WELFARE LATEX ) | Brilliant Ray Intl., Inc. | 1989-05-25 | 56 | 0 |
| K892024 | PATIENT EXAM GLOVES (MFG. CHAGAN TANG CAPITOL) | Brilliant Ray Intl., Inc. | 1989-05-25 | 56 | 0 |
| K892025 | PATIENT EXAM GLOVES (MFG. BEIJING LATEX FACTORY) | Brilliant Ray Intl., Inc. | 1989-05-25 | 56 | 0 |
| K892109 | PATIENT EXAMINATION GLOVES (LATEX) | Brilliant Ray Intl., Inc. | 1989-05-04 | 31 | 0 |
| K891739 | PATIENT EXAM GLOVE (LATEX) MFG. TIANJIN JI COUNTY | Brilliant Ray Intl., Inc. | 1989-04-14 | 23 | 0 |
| K891740 | PATIENT EXAM GLOVES (LATEX) MFG. TIANJIN KANG BAO | Brilliant Ray Intl., Inc. | 1989-04-14 | 23 | 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