Surgeon Glove Overview
Surgical gloves are personal protection equipment (PPE) designed to protect clinicians in operating room (OR) environments. The primary purpose of surgical gloves is to act as a protective barrier for surgeons and nurses to prevent possible transmission of diseases or pathogens during procedures while working with surgical instruments. Similar to medical examination glove, surgical glove standards are governed by the Food and Drug Administration (FDA) within the United States. However, the FDA requires manufacturers to meet a higher level of quality standards for surgical gloves.
Surgical Glove Properties
Material - Today, the vast majority of surgical gloves are still made from latex, natural rubber. During the early 1990s, latex allergy awareness has paved way for additional material to be introduced in the manufacturing of medical gloves. As surgeons sought out synthetic alternatives, neoprene surgical gloves were introduced. Manufacturers quickly standardized their offering to include a synthetic surgical glove made out of neoprene. Although neoprene surgical gloves are latex-free, veteren surgeons still preferred the traditional latex gloves since latex provides a higher level of elasticity and comfort. To solve this issue, polyisoprene was introduced. Polyisoprene surgical gloves have very similar properties of latex without containing the harmful proteins responsible for latex sensitivity. Although polyisoprene is more expensive than latex or neoprene, market share for polyisoprene surgical gloves continue to increase.
Sterile - All surgical gloves are sterilized and package sealed in pairs for individual use. The sterilization of surgical gloves is standard as surgical procedures often involve open wound operation.
Left/Right Hand Fitted - In contrast to medical exam gloves, surgical gloves are form fitted meaning every pair contains one glove shaped for the left hand and one glove shaped for the right hand. This is to ensure the highest level of comfort to help reduce fatigue from long surgical procedures.
Glove Size - Surgical glove sizes range from 5.5 to 9 in increments of 0.5. The variety of size options ensure the best fitting glove will be available for every surgeon. To view the medical glove size chart, Click Here.
FDA Requirements - Surgical Medical Gloves
The Food and Drug Administration (FDA) governs manufacturing standards for surgical gloves to ensure these medical devices meet certain performance criteria such as leak resistance and barrier strength.
| FDA Requirements - ASTM Standards | |
|---|---|
| AQL Level for Holes | 1.5 |
| Tensile Strength (before aging) | 24 MPa |
| Tensile Strength (after aging) | 18 MPa |
| Elongation (before aging) | 750% |
| Elongation (after aging) | 550% |
Acceptable Quality Level (AQL) - From 12/29/2008, the AQL standard for surgical gloves will be 1.5. This FDA increased the AQL requirement to ensure manufacturers are making medical gloves with minimal barrier defects such as pinholes.
Tensile Strength - The FDA requires surgical gloves to have tensile strength of at least 24 MPa (before aging). The tensile strength of the glove indicates the amount of force the glove can take before breaking. The higher the tensile strength, the stronger the surgical glove is.
Elongation - The FDA requires surgical gloves to have elongation of at least 750% (before aging). The elongation measurement indicates how far the glove can stretch before breaking. 750% elongation means the surgical glove material must be able to stretch 7.5 times from its original form. The higher the elongation measurement, the higher quality the surgical glove is.
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