Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tomarc (M) Sdn Bhd — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
206 daysmedian FDA review time
368 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931633 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVES | Tomarc (M) Sdn Bhd | 1993-10-25 | 206 | 0 |
| K923589 | STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV | Tomarc (M) Sdn Bhd | 1993-07-23 | 368 | 0 |
| K892899 | STERILE LATEX SURGICAL GLOVE | Tomarc (M) Sdn Bhd | 1990-01-17 | 272 | 0 |
| K890440 | LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER) | Tomarc (M) Sdn Bhd | 1989-05-12 | 105 | 0 |
| K890344 | GLOVES, PATIENT EXAMINATION | Tomarc (M) Sdn Bhd | 1989-04-26 | 93 | 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