Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
High Momentum 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) |
|---|---|---|---|---|---|
| K071207 | MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES | High Momentum Sdn Bhd | 2007-08-07 | 98 | 0 |
| K071208 | MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES | High Momentum Sdn Bhd | 2007-07-30 | 90 | 0 |
| K071209 | MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES | High Momentum Sdn Bhd | 2007-07-25 | 85 | 0 |
| K060858 | LATEX POWDERED EXAMINATION GLOVE | High Momentum Sdn Bhd | 2006-06-08 | 71 | 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