FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM— 510(k) K000813
Substantially EquivalentAllegiance Healthcare Coporation
FDA 510(k) clearance K000813 for FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM, Substantially Equivalent on 2000-06-08. Applicant: Allegiance Healthcare Coporation.
Clearance details
- Applicant
- Allegiance Healthcare Coporation
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgaw Park, IL, US
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.