POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR— 510(k) K041848
Substantially EquivalentPt. Smartglove Indonesia
FDA 510(k) clearance K041848 for POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR, Substantially Equivalent on 2004-08-20. Applicant: Pt. Smartglove Indonesia.
Clearance details
- Applicant
- Pt. Smartglove Indonesia
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tg Morawa-Deli Serdang, ID
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.