Sterile gloves are defined as sterile when they meet the FDA standards for sterilization techniques. Non-sterile gloves are not usually sterilized by the manufacturer of the gloves, but still must be tested by the FDA after sterilization to ensure that they meet the FDA’s standard assurance level (SAL) for sterilization techniques.
It is important to note that non-sterile gloves are typically used for non-surgical medical procedures and examinations. Sterile gloves are used to carry out surgical procedures.
All of our medical grade gloves including Ultra-Flex, Response ER, Ninja Black, Black Widow, NitraFlex, Grape Grip, Med-Edge, Protector XR, Chameleon, Sensi-Flex, and Med-Edge vinyl gloves are non-sterile.
One of the main differences between non-sterile and sterile gloves is the AQL or the acceptable quality level of pinholes. Surgical gloves have a lower AQL than non-sterile gloves, with sterile gloves AQL at 1.0 to 1.5 and non-sterile gloves AQL at 1.5 to 2.5. The number refers to the gloves in the sample that will have pinholes. So, for example, about 1.5 to 2.5% of the non-sterile sample gloves would have a pinhole. An AQL of 1 means that 1% of the gloves will have pinholes, and so on.