MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES— 510(k) K071208
Substantially EquivalentHigh Momentum Sdn Bhd
FDA 510(k) clearance K071208 for MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES, Substantially Equivalent on 2007-07-30. Applicant: High Momentum Sdn Bhd.
Clearance details
- Applicant
- High Momentum Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Selangor Daurl 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.