POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK— 510(k) K083717
Substantially EquivalentGx Corporation Sdn Bhd
FDA 510(k) clearance K083717 for POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK, Substantially Equivalent on 2009-01-30. Applicant: Gx Corporation Sdn Bhd.
Clearance details
- Applicant
- Gx Corporation Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Klang, Selang Darul Ehsan, 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.