Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)— 510(k) K211547
Substantially EquivalentEdma Group, LLC
FDA 510(k) clearance K211547 for Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs), Substantially Equivalent on 2021-07-15. Applicant: Edma Group, LLC.
Clearance details
- Applicant
- Edma Group, LLC
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, 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.