Tomarc (M) Sdn Bhd: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Tomarc (M) Sdn Bhd” (first 1989, latest 1993), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 206 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 3 | 3 |
| JTN | Susceptibility Test Discs, Antimicrobial | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (4)
- Microbiology (1)
Most recent Tomarc (M) Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931633 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVES | LYY | 1993-10-25 | 206 |
| K923589 | STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV | LYY | 1993-07-23 | 368 |
| K892899 | STERILE LATEX SURGICAL GLOVE | KGO | 1990-01-17 | 272 |
| K890440 | LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER) | LYY | 1989-05-12 | 105 |
| K890344 | GLOVES, PATIENT EXAMINATION | JTN | 1989-04-26 | 93 |
Recalls
openFDA lists no recalls under a recalling firm named Tomarc (M) Sdn Bhd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tomarc (M) Sdn Bhd?
FDA lists 5 510(k) clearances under the applicant name “Tomarc (M) Sdn Bhd” (first 1989, latest 1993), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tomarc (M) Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tomarc (M) Sdn Bhd is 206 days.
Which FDA product codes appear under Tomarc (M) Sdn Bhd?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 3); JTN (Susceptibility Test Discs, Antimicrobial, 1); KGO (Surgeon'S Gloves, 1).
Next steps
- See all 5 Tomarc (M) Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Tomarc (M) Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.