Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Top Calibre Sdn Bhd — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
133 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133949 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANG | Top Calibre Sdn Bhd | 2014-04-08 | 106 | 0 |
| K123819 | MULTIPLE NAME | Top Calibre Sdn Bhd | 2013-03-05 | 83 | 0 |
| K120692 | LATEX EXAMINATION GLOVES (POWDER FREE) | Top Calibre Sdn Bhd | 2012-05-14 | 68 | 0 |
| K120693 | LATEX EXAMINATION GLOVES (POWDERED) | Top Calibre Sdn Bhd | 2012-05-08 | 62 | 0 |
| K112612 | POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CO | Top Calibre Sdn Bhd | 2012-01-18 | 133 | 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