AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)— 510(k) K211310
Substantially EquivalentMegine Industries Sdn Bhd
FDA 510(k) clearance K211310 for AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange), Substantially Equivalent on 2021-06-16. Applicant: Megine Industries Sdn Bhd.
Clearance details
- Applicant
- Megine Industries Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kuala Lumpur, 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.