BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE— 510(k) K090464
Substantially EquivalentPt Mahakarya Inti Buana
FDA 510(k) clearance K090464 for BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE, Substantially Equivalent on 2009-04-23. 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
- Tanjung 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.