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The Required Medical Glove Certifications

The Required Medical Glove Certifications

The Required Medical Glove Certifications

medical glove certifications
The required certifications per glove material and country

Examination and medical gloves are one of the most vital and largest spending sources in supply budgets for every healthcare facility. But how can you be sure that you are purchasing the right gloves for each task cost-effectively? Neobex can help you better understand the medical gloves industry with the final section of the glove guide. However, this section is one of the most important in the guide as it concerns the medical glove certifications.

Key Takeaways

  • Countries have different restrictions for selling medical gloves.
  • Certifications that a diligent gloves buyer must verify are the ASTM’s.
  • Make sure that Latex is ASTM D3578, Nitrile ASTM 6319, Vinyl ASTM D5250, and Blend ASTMD5250. Consequently this means that all the other certifications are included.

The Different Organizations

ASTM

ASTM International, formerly known as the American Society for Testing and Materials, is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Their goal is to establish compliance across different products.

ISO

The International Organization for Standardization is an international standard-setting body composed of representatives from various national standards organizations. ISO oversees the development of tests and success criteria. Their goal is to establish test compliance with standardization organizations such as ASTM.

CE

CE marking is an administrative marking with which the manufacturer or importer affirms its conformity with European health, safety, and environmental protection standards for products sold within the European Economic Area. They establish the EN standards to be respected according to the product tested.

Overview of the ASTM Certifications

medical glove certifications
Overview of the certifications per glove material

The Certifications Explained

Tests

Level of appreciation

Description

ASTM D5151

Presence of pinholes

The holes are small enough to prevent water from leaving the glove

The goal is to detect if the pinholes (which can never be 100% removed) are small enough to prevent liquids from entering and exiting the gloves. The test consists of filling the gloves with water (1000 ml), hanging them upside down, and observing if the liquid escapes for two minutes. If no liquid escapes, the test is considered a success and then we can move on to the other tests. You can also add the sample test, which involves filling them with air to detect any weak points, holes, or other deformations.

ASTM D6124

Powder-free

Maximum of 2 mg of powder per glove

The test method consists of determining the level of residual powder on medical gloves. This powder can cause skin irritation or a rather severe reaction when it encounters a wound or a cut on the patient. The test involves rinsing the gloves individually with water, then we filter the water to collect the powder residue. We then calculate the amount of powder using a scale to ensure that it does not exceed 2 mg.

ASTM D5712

Low levels of protein

Less than 50 mg of protein per glove

This test method covers an analytical test for determining the amount of total aqueous extractable protein associated with natural rubber (NR) and its products. Water-soluble proteins are extracted in a buffer solution and then precipitated to concentrate and separate them from water-soluble substances that may interfere with the determination.

ASTM D3767

Conformity of sizes

Dimensions respect the industry’s size conformity

Measure the dimensions of the gloves according to the size chosen in millimeters. The length is measured from the end of the second finger to the end of the wrist, using a tape measure. The width is measured by the ends of the palm, using a tape measure. The thickness is measured at the location of the second finger using a tool such as a laser thickness gauge.

ASTM D573

Thermal resistance

The glove is heat resistant

Measure the degradation of gloves by heat, i.e., the thermal resistance of the product. The test consists of placing a glove in an air oven, at a temperature maintained at 70 Celsius ± 2 Celsius for a duration of 166 hours. We then look at the results to make sure the glove retains all its protective properties even after long exposure to heat.

ASTM D6499

Rubber Immunity

Natural rubber protein immunity

This test method covers an immunological method to determine the amount of antigenic protein in Hevea Natural Rubber and its products using rabbit antisera specific for HNRL proteins. This immunoassay procedure quantitatively measures the level of antigenic latex proteins in a solution using an inhibition format.

ASTM D412

Tensile proprieties

The glove will not rupture before it reaches a certain stretching force

The glove will be stretched over a certain period until it reaches the targeted newton force (which depends on the material the glove is made of).

ASTM F1671

Resistance to pathogens

The glove is resistant to Exposure to pathogens

This test method is used to measure the resistance of materials used in protective clothing to the penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral penetration.

ASTM F739

Prolongated exposition to liquid

The glove is resistant to Exposure to pathogens

This test method measures the permeation of liquids and gases through protective clothing materials under the condition of continuous contact. The test chemical did not pierce the sample at a rate greater than 0.1 g / cm2 / min within the designated time if the normalized breakthrough time is greater than a certain period. During this period, permeation may or may not have occurred at a slower rate.

ASTM D6978

Chemotherapy drugs

Resistance of glove materials to permeation of cancer chemotherapy drugs

Protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period.

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