Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask— 510(k) K202595
Substantially EquivalentPremier Guard USA, LLC
FDA 510(k) clearance K202595 for Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask, Substantially Equivalent on 2021-01-21. Applicant: Premier Guard USA, LLC.
Clearance details
- Applicant
- Premier Guard USA, LLC
- Product code
- Code FXX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jackson, MS, US
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
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.