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Copioumed
Copious International Inc. · Model IGN0B2060-1 · UDI-DI 04719882253263
10
510(k) clearances
28
Adverse events
2
Recalls
56
Facilities
Description
Copioumed Isolation gown is made of non-woven fabric, breathable, avoid dust and liquid penetration. It can cover the body and all clothing, forming a physical barrier to prevent the spread of substances such as microorganisms. In order to protect the safety of medical staff and avoid the secondary infection of patients.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-01 | Cardinal Health 200, LLC | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancem |
| 2024-11-01 | Cardinal Health 200, LLC | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancem |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.