Top Calibre Sdn Bhd: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Top Calibre Sdn Bhd” (first 2012, latest 2014), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 83 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 | 3 | 68 |
| 2013 | 1 | 83 |
| 2014 | 1 | 106 |
| 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 | 4 | 4 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Top Calibre Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133949 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | 2014-04-08 | 106 |
| K123819 | MULTIPLE NAME | LYY | 2013-03-05 | 83 |
| K120692 | LATEX EXAMINATION GLOVES (POWDER FREE) | LYY | 2012-05-14 | 68 |
| K120693 | LATEX EXAMINATION GLOVES (POWDERED) | LYY | 2012-05-08 | 62 |
| K112612 | POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM | LYY | 2012-01-18 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Top Calibre 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 Top Calibre Sdn Bhd?
FDA lists 5 510(k) clearances under the applicant name “Top Calibre Sdn Bhd” (first 2012, latest 2014), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Top Calibre Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Top Calibre Sdn Bhd is 83 days.
Which FDA product codes appear under Top Calibre Sdn Bhd?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); LZA (Polymer Patient Examination Glove, 1).
Next steps
- See all 5 Top Calibre Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Top Calibre 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.