Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Seltom Pacific Sdn. Bhd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
98 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011924 | POWDERED BLUE NITRILE EXAMINATION GLOVES | Seltom Pacific Sdn. Bhd. | 2001-07-10 | 20 | 0 |
| K011922 | POWDERED LATEX EXAMINATION GLOVES | Seltom Pacific Sdn. Bhd. | 2001-07-05 | 15 | 0 |
| K003934 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABEL | Seltom Pacific Sdn. Bhd. | 2001-01-26 | 37 | 0 |
| K991777 | LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING C | Seltom Pacific Sdn. Bhd. | 1999-08-31 | 98 | 0 |
| K991778 | LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE) | Seltom Pacific Sdn. Bhd. | 1999-08-31 | 98 | 0 |
| K991779 | NITRILE EXAMINATION GLOVES POWDER FREE (BLUE) | Seltom Pacific Sdn. Bhd. | 1999-08-11 | 78 | 0 |
| K991776 | NITRILE EXAMINATION GLOVES POWDER FREE (WHITE) | Seltom Pacific Sdn. Bhd. | 1999-08-11 | 78 | 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