Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)— 510(k) K162146
Substantially EquivalentBrightway Holdings Sdn. Bhd.
FDA 510(k) clearance K162146 for Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender), Substantially Equivalent on 2017-01-05. Applicant: Brightway Holdings Sdn. Bhd..
Clearance details
- Applicant
- Brightway Holdings Sdn. Bhd.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Klang, 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.