3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation is an FDA 510(k)-cleared medical device (K210605) manufactured by 3M Company. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 28, 2021. Regulation: 8.