Disposable gloves are considered sterile when they meet or exceed the FDA’s standard assurance level for sterilization. When it comes to sterile vs. non sterile gloves, for the vast majority of uses non-sterile gloves are adequate. Sterile gloves are used for surgeries and wound care while non-sterile gloves are used for everything from common medical procedures to food preparation.
The process for meeting the FDA’s guidelines for sterile gloves include an expanded sterilization process, meeting higher acceptable quality levels, packaging requirements and meeting a rigorous testing and compliance process.
FDA Assurance & Quality for Gloves
The primary test for glove quality in regards to attaining the level of sterile is the acceptable quality level (AQL) of pin holes in each glove.
Sterile gloves are allowed an AQL of 1%-1.5% while non sterile gloves meet an AQL for pin holes of 1.5%-2.5%.
Both types of gloves will be sterilized but non-sterile gloves are often sterilized by a third party. To meet the FDA’s requirements sterile gloves are carefully sterilized in house. When the requirements for sterilization are met there is only a 1 in 1,000,000 chance that a pair would be considered non sterile according to the FDA’s guidelines.
Tolerances and manufacturing processes as well as sterilization processes are regularly inspected by the FDA. The sterilization process kills even highly resistant micro organisms and the standard assurance levels for sterile gloves are confirmed before packaging.
Packaging Requirements for Sterile vs. Non Sterile Gloves
Sterile gloves are usually packaged 1 pair per pouch and the boxes are much bigger so gloves aren’t easily damaged when removing them. Non-sterile gloves are often packed so tight that they will stretch and sometimes tear when you remove one from a full box.
By packaging each pair of gloves individually it keeps workers from contaminating other pairs of gloves when they need to use a pair.
Uses for Sterile and Non Sterile Gloves
Since non-sterile gloves are much cheaper they are used for almost all procedures that are not considered surgical.
Ashley Rietz, MD advises physicians that it is acceptable to use non sterile gloves for minor skin excisions because the infection rate is not increased compared to using sterile gloves.
Tattoo artists mostly use non-sterile gloves, but it is recommended that they use sterile gloves when handling sterile equipment.
The primary use of a glove is to provide a barrier between the user’s skin and surfaces or objects that they do not want to contaminate or do not want to contaminate their body. For the vast majority of uses non-sterile gloves are adequate. Sterile gloves are primarily used for surgeries and wound care where the glove can come in contact with deep tissue.
Sterile gloves are also often used in clean rooms, aerospace, electronic manufacturing, chemical engineering, laboratories and medical applications where contamination is highly regulated.