FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE— 510(k) K042239
Substantially EquivalentPt. Mandiri Inti Buana
FDA 510(k) clearance K042239 for FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE, Substantially Equivalent on 2004-12-16. Applicant: Pt. Mandiri Inti Buana.
Clearance details
- Applicant
- Pt. Mandiri 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.