ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES— 510(k) K970015
Substantially EquivalentEci Medical Technologies, Inc.
FDA 510(k) clearance K970015 for ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES, Substantially Equivalent on 1997-06-24. Applicant: Eci Medical Technologies, Inc..
Clearance details
- Applicant
- Eci Medical Technologies, Inc.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgewater, Nova Scotia, CA
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.