Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black— 510(k) K220121
Substantially EquivalentAamedix Glove Sdn Bhd
FDA 510(k) clearance K220121 for Non Sterile Nitrile Powder Free Examination Gloves Blue,Green, and Black, Substantially Equivalent on 2022-04-11. Applicant: Aamedix Glove Sdn Bhd.
Clearance details
- Applicant
- Aamedix Glove Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Selanger Darul Ehsan, MY
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.