Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Perusahaan Intan Emas 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) |
|---|---|---|---|---|---|
| K982691 | MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTE | Perusahaan Intan Emas Sdn. Bhd. | 1998-10-09 | 67 | 0 |
| K935033 | MULTI-COMFORT POWDER FREE | Perusahaan Intan Emas Sdn. Bhd. | 1994-02-02 | 105 | 0 |
| K925363 | HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES | Perusahaan Intan Emas Sdn. Bhd. | 1993-07-06 | 257 | 0 |
| K892074 | PATIENT EXAMINATION GLOVES (LATEX) | Perusahaan Intan Emas Sdn. Bhd. | 1989-04-28 | 25 | 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