ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE— 510(k) K110960
Substantially EquivalentKoon Seng Sdn Bhd
FDA 510(k) clearance K110960 for ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE, Substantially Equivalent on 2011-07-14. Applicant: Koon Seng Sdn Bhd.
Clearance details
- Applicant
- Koon Seng Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenwood Village, CO, 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.