Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy— 510(k) K213548
Substantially EquivalentMercator Medical (Thailand), Ltd.
FDA 510(k) clearance K213548 for Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy, Substantially Equivalent on 2022-02-21. Applicant: Mercator Medical (Thailand), Ltd..
Clearance details
- Applicant
- Mercator Medical (Thailand), Ltd.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Amphur Rattaphum, TH
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.