Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)— 510(k) K211457
Substantially EquivalentAmmex Corporation
FDA 510(k) clearance K211457 for Powder Free Nitrile Examination Gloves (Blue, Black, Indigo), Substantially Equivalent on 2021-12-18. Applicant: Ammex Corporation.
Clearance details
- Applicant
- Ammex Corporation
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kent, WA, 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.