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Nitrile Examination Gloves
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K222813
Identifiers
- 510(k) Number
- K222813 FDA 510(k)
- FDA Product Code
- LZA FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6250 FDA 510(k)
- Regulation Number
- 880.6250 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Nitrile Examination Gloves by Ecoglove Medical Manufacturing Company Limited — Class I — MDR, FDA_510K — listed in FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K222813 | Class I | Active |
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Manufacturer
- Manufacturer
- Ecoglove Medical Manufacturing Company Limited
Sources (2)
- FDA 510(k) K222813 24 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced May 18, 2026