Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield— 510(k) K171162

Substantially Equivalent

Prestige Ameritech

FDA 510(k) clearance K171162 for Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield, Substantially Equivalent on 2017-08-15. Applicant: Prestige Ameritech.

Clearance details

Applicant: Prestige Ameritech
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2017-04-20
Decision date: 2017-08-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Richland Hills, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.