BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free— 510(k) K213408
Substantially EquivalentMeditech Gloves Sdn Bhd
FDA 510(k) clearance K213408 for BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free, Substantially Equivalent on 2022-04-17. Applicant: Meditech Gloves Sdn Bhd.
Clearance details
- Applicant
- Meditech Gloves Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nilai, 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.