Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Copioumed International, Inc. with 10 510(k) clearances. The most recent is a 510(k) clearance dated Feb 26, 2026: Copioumed AAMI 3 Surgical Gown.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 26, 2026 | Copioumed AAMI 3 Surgical GownK251860 · FYA | 510(k) clearances |
| Oct 4, 2023 | Copioumed Chemotherapy Isolation GownK230135 · FYC | 510(k) clearances |
| Apr 17, 2003 | POWDERED VINYL EXAM GLOVES, WHITEK030927 · LYZ | 510(k) clearances |
| Jul 2, 2002 | POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITEK021961 · LYZ | 510(k) clearances |
| Jun 10, 2002 | (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOWK021743 · LZA | 510(k) clearances |
| Nov 6, 1997 | POLY (VINYL) EXAM GLOVE, POWDER-FREEK972624 · LYZ | 510(k) clearances |
| Aug 27, 1997 | POLY (VINYL) EXAM GLOVE, POWDEREDK971316 · LYZ | 510(k) clearances |
| Aug 27, 1997 | NURSES BOUFFANT CAPK965237 · LYU | 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
