Fusion Black Powder-Free Nitrile Exam Glove— 510(k) K150113
Substantially EquivalentHalyard Health
FDA 510(k) clearance K150113 for Fusion Black Powder-Free Nitrile Exam Glove, Substantially Equivalent on 2015-06-18. Applicant: Halyard Health.
Clearance details
- Applicant
- Halyard Health
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Roswell, GA, 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.