Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves— 510(k) K220825
Substantially EquivalentAmerican Nitrile Operations, LLC
FDA 510(k) clearance K220825 for Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves, Substantially Equivalent on 2022-07-08. Applicant: American Nitrile Operations, LLC.
Clearance details
- Applicant
- American Nitrile Operations, LLC
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Grove City, OH, US
Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.