MICRO-TOUCH Denta-Glove NRL

31/03/2021 By: Dental Education Hub Infection Control, News 0 Comment

Gloves are critical personal protective equipment (PPE) used in multiple industries and professions to prevent direct contact between a potential harmful microorganism, chemical, object, solution or surface and the wearer’s hand(s). In healthcare, gloves are used primarily as a barrier to prevent a healthcare worker (HCW) from having direct contact with a contaminated surface, an infectious patient, blood and body fluids and/or harmful solutions or chemicals. As well, patients are protected from contamination by the HCW’s hands when the HCW wears gloves.

Timing of glove use and removal is an important aspect of infection prevention. So too is selection of a glove appropriate for the task. The wide variety of tasks typically required of HCWs range from specific grasping situations, handling of power tools, rapid donning in emergencies, palpation of skin, the need to determine surface temperature and contact with rough and jagged edges of either equipment or bone shards. There are many other tasks requiring different features of gloves. Whilst the clinical situations are diverse the range and performance attributes of commonly available gloves are comparatively limited. Typically, HCWs select gloves according to their fit, elasticity, tactility and ease of donning. Comfort is of special significance to HCWs including surgeons, who typically are required to wear gloves for extended periods. Glove fit and avoiding hand fatigue are critically important in these cases as is the durability of the glove and its ability to withstand operating conditions without tearing, breaking or leaking (Mylon,Lewis, Carre, Martin, & Brown, 2014). Torn or broken gloves are inefficient barriers and potentially predispose the transfer of infectious agents from or to the HCW’s hand or the patient or touched surfaces.

Glove Standard specifications address characteristics or factors such as:

Performance and efficacy.
Biocompatibility with blood, saline and any intended chemical contact.
Powder levels.
Allergenicity (chemicals and proteins).
Pinhole and Acceptable Quality Level (AQL).
Barrier integrity (tensile strength and elongation).
Length, cuff, size, color, odor, and thickness.
Human factor, fatigue and donning.
Packaging and Labelling; if applicable special labelling claims such as chemotherapy.
Shipping Stability and Shelf Life

How to select quality gloves:

Powder-Free

Gloves with trace amounts of residual former-release powder (2 mg or less per glove) and no intentionally added donning powders are commonly referred to as “powder free.”

Protein Level Claims

Manufacturers who can reliably reduce the levels of latex proteins in their gloves to a known level may make a labelling claim. At present, U.S. Food and Drug Administration (FDA) does not allow a protein labelling statement or claim below the current 50μg/dm2 sensitivity limit of the ASTM Lowry Test Method (D5712).

Chemical Sensitization Claims

Certain chemicals used in the manufacture of medical gloves, can cause skin sensitization and irritation. If manufacturers sufficiently reduce or eliminate the presence of these chemicals, they may make appropriate labelling claims regarding the reduced potential of chemical sensitization.

Biocompatibility

Biocompatibility is the quality of being compatible with living tissue by not being toxic or injurious and not causing immunological reactions. In a regulatory sense, biocompatibility is testing to determine the potential toxicity resulting from bodily contact with a medical device. Because medical gloves are in direct contact with skin, a primary skin irritation study and a dermal sensitization study are appropriate. Further, should a glove contain a color, flavor and /or scent additives it should be submitted for biocompatibility testing to demonstrate the safety of the additives.

Barrier Integrity – Tensile Strength and Elongation

Specific standard tests that gloves must meet during manufacture and simulated conditions similar to real-time working conditions are included in the Standards to ensure that gloves are capable of withstanding specific force and stresses including stretching. This ensures that gloves are able to withstand certain pressures beyond those that would be required when worn under typical working conditions and durations.

AQL – Freedom from Holes

Manufacturers must subject a specific proportion of gloves they manufacture to testing for water tightness according to a specific testing protocol. Water tightness testing is one way that the quality of gloves in terms of freedom from holes can be assessed. Passing this test is one way of proving that gloves provide an adequate barrier against bi-directional transfer of microbes between patients or contaminated surfaces and glove wearers. The next section reviews Acceptable Quality Level specifications in further detail according to various International Standards.

What is an acceptable quality level (AQL)?

AQL is an industry standard. It is a statistical sampling process for evaluating quality. According to the International Standards Organization (ISO) (2859-1: 1999)a, AQL is “the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling”. Process average is the typical percentage of defective gloves in the lots/batches sampled. A General Inspection Level is allocated to designate the relative amount of gloves inspected.

What standards apply for AQL?

Various International Standards, determine the AQL that manufacturers must comply to. However, manufacturers can set their own standards as long as they are stricter than the international standards. The lower the AQL, the lower the chance of finding a defect in the batch of gloves and the higher the quality of the product.

How is the acceptable quality level determined?

Glove AQL is determined by manufactured lot size, the sampling plan inspection level set by the corresponding international standards, which is the number of gloves randomly selected to be tested and the AQL level also set by the Standards. This calculates the allowable number of nonconformities/imperfections for every glove lot produced. The standards stipulate the minimum AQLs for lot-by-lot inspection against specific criteria such as physical dimensions (width, length and thickness), water tightness, tensile strength and elongation at break (before and after accelerated ageing). The standards also prescribe standardized testing. AQLs commonly required in glove manufacture include air and water tests to indicate any defective glove areas.

At their discretion, manufacturers may routinely choose to produce a glove or range of gloves that exceed the minimum international and national standards. Exceeding these standards gives a higher degree of assurance that the risk of defective gloves in a sampling plan is closer to zero.

MICRO-TOUCH® DENTA-GLOVE® NRL

Latex, powder-free, examination glove with maximum comfort for a wide range of dental procedures.

This non-sterile glove is an ideal choice for dental specialists who switch gloves frequently and experience hand fatigue from continuous use.

Latex formulation and optimised film thickness offer a high level of elasticity, flexibility and sensitivity
Inner chlorinated surface to ensure fast and easy donning
Tested safe for oral examination, ensuring that the glove is safe for patient contact