Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Aearo Company
Free shipping on orders over $99 · 30-day returns
PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S is an FDA 510(k)-cleared medical device (K063013) manufactured by Aearo Company. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 30, 2006. Regulation: 8.