Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)— 510(k) K210944
Substantially EquivalentHarbour Health, LLC
FDA 510(k) clearance K210944 for Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue), Substantially Equivalent on 2021-04-29. Applicant: Harbour Health, LLC.
Clearance details
- Applicant
- Harbour Health, LLC
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newport Beach, CA, 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.