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PRODUCT PROPERTIES If worn by the caregiver, the surgical mask protects the patient and his or her environment (air, surfaces, equipment, surgical site). If worn by a contagious patient, it prevents the patient from contaminating his or her surroundings and environment. These masks should not be worn for more than 3 to 8 hours. A surgical mask can also protect the wearer from the risk of splashes of biological fluids. In this case, the surgical mask must have a waterproof layer. Limitation of this mask- a surgical mask does not protect against airborne infectious agents so it will not prevent the wearer from being potentially contaminated by a virus such as the coronavirus. We have both FDA and CE approved and non-FDA approved based on different countries requirement and regulations TECHNICAL SPECIFICATIONS ITEM TEST METHOD STANDARD TEST RESULT INCLUDE BFE (%) YY0469-2011 95 96.2 Qualified PFE (%) YY0469-2011 30 93.8 Qualified Synthetic Blood Penetration Resistance YY0469-2011 No Penetration No Penetration Qualified Airflow Resistance (Pa) YY0469-2011 49 41.1 Qualified Flame Resistance YY0469-2011 Nonflammable Nonflammable Qualified