Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color— 510(k) K162312
Substantially EquivalentShen Wei USA, Inc.
FDA 510(k) clearance K162312 for Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color, Substantially Equivalent on 2017-07-25. Applicant: Shen Wei USA, Inc..
Clearance details
- Applicant
- Shen Wei USA, Inc.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Union City, CA, US
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.