Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in MalaysiaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Top Calibre with 5 510(k) clearances. The most recent is a 510(k) clearance dated Apr 8, 2014: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED….
| Apr 8, 2014 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGSK133949 · LZA | 510(k) clearances |
| Mar 5, 2013 | MULTIPLE NAMEK123819 · LYY | 510(k) clearances |
| May 14, 2012 | LATEX EXAMINATION GLOVES (POWDER FREE)K120692 · LYY | 510(k) clearances |
| May 8, 2012 | LATEX EXAMINATION GLOVES (POWDERED)K120693 · LYY | 510(k) clearances |
| Jan 18, 2012 | POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIMK112612 · LYY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
