SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)— 510(k) K080165
Substantially EquivalentPlatinum Glove Industries Sdn. Bhd.
FDA 510(k) clearance K080165 for SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY), Substantially Equivalent on 2008-05-14. Applicant: Platinum Glove Industries Sdn. Bhd..
Clearance details
- Applicant
- Platinum Glove Industries Sdn. Bhd.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shah Alam, 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.