NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE— 510(k) K053366
Substantially EquivalentPt Mahakarya Inti Buana
FDA 510(k) clearance K053366 for NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE, Substantially Equivalent on 2006-03-30. Applicant: Pt Mahakarya Inti Buana.
Clearance details
- Applicant
- Pt Mahakarya Inti Buana
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morawa, Sumut, 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.