Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mulpha Intl. Trading Corp. Bhd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
148 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891811 | PATIENT EXAM GLOVES (MFG. PALMBASE RUBBER MFG.) | Mulpha Intl. Trading Corp. Bhd. | 1989-08-18 | 148 | 0 |
| K891812 | PATIENT EXAM GLOVES (MFG. GETAH GAYAL) | Mulpha Intl. Trading Corp. Bhd. | 1989-08-18 | 148 | 0 |
| K891813 | PATIENT EXAM GLOVES (MFG. AEK RUBBER PRODUCTS) | Mulpha Intl. Trading Corp. Bhd. | 1989-08-18 | 148 | 0 |
| K891816 | PATIENT EXAM GLOVES (MFG. HEALTHCARE GLOVES) | Mulpha Intl. Trading Corp. Bhd. | 1989-08-18 | 148 | 0 |
| K891817 | PATIENT EXAM GLOVES (MFG. TERANG NUSA) | Mulpha Intl. Trading Corp. Bhd. | 1989-08-18 | 148 | 0 |
| K891815 | PATIENT EXAM GLOVES (MFG. M.R. RUBBER INDUSTRIES) | Mulpha Intl. Trading Corp. Bhd. | 1989-08-15 | 145 | 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