ROYAL GUARD— 510(k) K092617
Substantially EquivalentShun Thai Rubber Gloves Industry Public Co., Ltd.
FDA 510(k) clearance K092617 for ROYAL GUARD, Substantially Equivalent on 2010-05-20. Applicant: Shun Thai Rubber Gloves Industry Public Co., Ltd..
Clearance details
- Applicant
- Shun Thai Rubber Gloves Industry Public Co., Ltd.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alexandria, VA, 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.