Disposable Gloves Guide
Disposable gloves are an indispensable component in a variety of settings, from industrial environments dealing with harsh chemicals to medical situations where exposure to bloodborne pathogens is a risk. These gloves undergo a meticulous inspection process after manufacturing and drying before they are packaged and sold. To ensure safety, particularly for exam-grade gloves, they must meet stringent criteria set forth by the US Food and Drug Administration (FDA). The gloves are tested for puncture resistance, abrasion resistance, tension, elongation, and chemical resistance.
The FDA has established acceptable quality limits (AQL) for glove inspection, which are compliant with standards set by the American Society for Testing and Materials (ASTM). The AQL methodology is a percentage-based quality assurance practice applicable to a sample of gloves. For instance, from a sample of 100 gloves with an AQL of 3.0, no more than three gloves can fail the tests. For medical-grade gloves, this AQL is typically 2.5 or lower. If the failure rate exceeds these limits, the entire sample is deemed unacceptable, prompting manufacturers to reassess their production processes. A lower AQL figure indicates a higher quality glove.
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Although a glove might not be labeled as “approved” by the FDA if it doesn’t comply with ASTM testing, it can still be “accepted,” highlighting that some manufacturers may not fully adhere to FDA requirements. This is particularly relevant for medical-grade gloves which have a stricter AQL due to the inherent risks in the medical field. Various tests are employed for quality verification, including the pinhole leak test that assesses barrier integrity crucial for medical usage. In this procedure, gloves are filled with one liter of water, sealed at the cuffs, and inverted to check for leaks. Only those that withstand this test without leaking are authorized for medical applications.
It is essential to note that the absence of formal certification doesn't automatically imply that a glove is unsafe. The labeling of “sterile” applies solely to surgical gloves that have undergone irradiation.
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