ASTM is a nonprofit organization that delivers a common ground for manufacturers, consumers, organizations, government representatives, and academia, to fulfill and write standards for variety of products, services, and materials. Its guidelines are completely recognized by the FDA. Consequently, glove manufacturers must conform to these standards to fulfill FDA requirements for the particular kind of medical gloves they market. Medical gloves, actually, were among the first products for which standards were developed by the ASTM.
Occasionally, the ASTM revises its standards to react to business, consumer and regulatory demands. Otherwise, the guidelines are reviewed every five years after which they are re-approved or withdrawn.
Different standards are required by the ASTM for different medical gloves based on performance specifications. Glove products are scientifically tested to accurately evaluate products made from various formulations production approaches and stuff. Demanding evaluation is conducted in a variety of areas, for instance:
- The Water Leak Test which consists of filling a medical glove with water and inspecting it for any holes.
- The Air Inflation Test which calls for inflating the examination glove with compressed air and visually inspecting it for holes.
- The Chemical Permeation Test which measures the resistance of protective clothing materials to permeation under conditions of continuous contact by gaseous or liquid chemicals.
- The Tensile Strength Test which measures the quantity of force in pounds per square inch that’s required to elongate a medical glove to the breaking point.
- The V-Tear Test which determines the force required to start a tear in the medical glove.
- The Trouser Tear Test which measures the force needed to continue once an initial rip continues to be made in the glove snapping.
- Skin irritation and sensitization tests which illustrate the medical glove’s potential for irritating the user’s skin and potentially causing allergic contact dermatitis