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Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
FDA 510(k)Class I (US FDA 510(k))
510(k) K220825
Identifiers
- 510(k) Number
- K220825 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)
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves by American Nitrile Operations, LLC — Class I — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220825 | Class I | Active |
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Manufacturer
- Manufacturer
- American Nitrile Operations, LLC
Sources (1)
- FDA 510(k) K220825 24 fields · synced Jun 18, 2026