POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES— 510(k) K081592
Substantially EquivalentQuality Gallant Sdn. Bhd.
FDA 510(k) clearance K081592 for POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES, Substantially Equivalent on 2008-12-03. Applicant: Quality Gallant Sdn. Bhd..
Clearance details
- Applicant
- Quality Gallant Sdn. Bhd.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taiping, Perak, 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.