NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE— 510(k) K083156
Substantially EquivalentGiga-Drive Sdn, Bhd
FDA 510(k) clearance K083156 for NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, Substantially Equivalent on 2009-05-08. Applicant: Giga-Drive Sdn, Bhd.
Clearance details
- Applicant
- Giga-Drive Sdn, Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ipoh, 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.