As the name suggests, surgical gloves are designed primarily for use in healthcare procedures posing the highest risk for the spread of bloodborne pathogens, but are also popular in cleanroom and other laboratory settings. These gloves are manufactured to the strictest specifications of any disposable glove type, and consequently are also the mostly costly. Typically, these gloves are sterile, but non-sterile surgical gloves are also sold.
In order to be labeled as surgical grade, gloves are randomly tested to ensure they meet strict performance standards enacted by the Food and Drug Administration (21 CFR 800.20). These standards loosely correspond to those first established by ASTM, which are widely regarded as the industry benchmarks for quality. In addition, manufacturers (including those outside the United States) are required to register with the FDA as part of a process referred to as 510k certification.
Examination grade gloves, also sometimes referred to as medical gloves, were originally designed for non-surgical medical procedures, but are also used in a variety of other applications where users seek added peace of mind regarding the glove quality. Exam gloves are sold both sterile and non-sterile.
As with surgical gloves, The Food and Drug Administration randomly tests glove quality to ensure gloves meet the agency’s quality requirements, which mirror ASTM standards, to be sold in the United States under the label examination grade. Manufacturers must also receive 510k certification.
Foodservice gloves, often referred to as multipurpose gloves, are designed for short-term use and frequent glove changes. No formal government regulations or inspection program exists for foodservice gloves. Instead, the USDA requires that all glove components comply with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) which allows for repeated use in direct contact with food.
ASTM standards for non-medical gloves do exist, but conformance to these standards is sporadic. Non-governmental, for-profit organizations have attempted to create standardized quality guidelines for foodservice, but these programs are largely repetitive with ASTM and carry substantial financial burdens for manufacturers.
Largely, the only difference between foodservice and industrial grade gloves lies with whether or not the gloves are made with USDA accepted materials. Industrial grade glove quality is not regulated by any US government agency and while an ASTM standard does exist for non-medical gloves, conformance to this standard is sporadic.