ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE— 510(k) K063777
Substantially EquivalentBright Element Sdn Bhd
FDA 510(k) clearance K063777 for ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE, Substantially Equivalent on 2007-02-23. Applicant: Bright Element Sdn Bhd.
Clearance details
- Applicant
- Bright Element Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Subang Jaya, Selangor, MY
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.