Understanding the Issues of Double Gloving
The demand by healthcare workers for new and improved gloving materials has been
the driving force behind the efforts of manufacturers to produce high-quality gloves
with outstanding performance capabilities. Surgical gloves are regulated as medical
devices and are under scrutiny by the U.S. Food and Drug Administration (FDA). All
gloves must meet acceptable quality levels for physical specifications, defect and
pinhole rates, elasticity, elongation, protein and powder levels, allergenicity
or biocompatibility.
The ASTM (American Society for Testing and Materials) sets the standards, and the
FDA and OSHA enforce them. All gloves meeting FDA requirements must provide adequate
barrier protection against pathogens such as HIV and HBV, and comply with the OSHA
Bloodborne Pathogen Standard. Manufacturers must also produce gloves that meet the
customer’s needs for durability, flexibility, tactile sensitivity and resiliency.
The gloves need to fit like a “second skin” for the surgeons that are performing
delicate microsurgical procedures and be flexible enough to touch the tiny hair-like
vessels of a premature infant’s heart, and have the durability to withstand the
rigor of the chisels and blades during a total joint replacement while providing
a barrier between the healthcare worker and the patient.
The material must meet stringent manufacturing standards and also stringent tactile
requirements at the same time – all of this while still providing acceptable fit,
feel and comfort throughout the procedure. This is no small order to fill. Manufacturers
have made great strides and improvements in gloves and have produced a large variety
of quality products for healthcare workers to choose from. Even with all the high
technology in manufacturing there are several factors that increase the likelihood
of glove ailure during use, including mechanical stress, type of surgery, number
of instruments used in the surgical case, length of surgical procedure the wearer’s
role in the surgical case.
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