Violet Nitrile Powder Free Patient Examination Glove, Non Sterile— 510(k) K210587
Substantially EquivalentOnetexx Sdn Bhd
FDA 510(k) clearance K210587 for Violet Nitrile Powder Free Patient Examination Glove, Non Sterile, Substantially Equivalent on 2021-06-28. Applicant: Onetexx Sdn Bhd.
Clearance details
- Applicant
- Onetexx Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kamunting, 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.