Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Slim River Latex 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) |
|---|---|---|---|---|---|
| K933224 | SLIMFLEX - POWDER FREE LATEX EXAMINATION GLOVES | Slim River Latex Sdn. Bhd. | 1994-03-15 | 257 | 0 |
| K926440 | POWDER-FREE EXAMINATION GLOVE | Slim River Latex Sdn. Bhd. | 1993-10-05 | 286 | 0 |
| K905033 | SLIMFLEX, PATIENT EXAMINATION GLOVES | Slim River Latex Sdn. Bhd. | 1990-11-19 | 12 | 0 |
| K904936 | PATIENT EXAMINATION GLOVES | Slim River Latex Sdn. Bhd. | 1990-11-08 | 7 | 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