Chemical Barrier Testing for gloves

While general medical gloves do not require chemical permeation or degradation testing, chemotherapy gloves do. The following is a discussion of relevant chemicals and test methodologies.

Chemotherapy/Cytotoxic Drug Testing
Gloves sold for chemotherapy use must pass chemical permeation challenges with numerous chemotherapeutic drugs. The test protocols and results must be reviewed and cleared by the FDA.

It is advisable that hospital materials managers require clearance documentation.
The chemotherapy drug challenge test study is not standardized. However, the method most frequently used is ASTM F73936 for continuous contact permeation studies of any chemicals on thin film protective materials. Physical testing may also be conducted on the glove after the permeation study is completed to determine if the physical properties have degraded. Because not every chemotherapeutic drug or combination of drugs can be anticipated, the drugs are divided into chemical families. Representatives from each of the drug families are used as the chemical test challenge. Basically, one layer of the glove is placed between two chambers. The drug being evaluated is placed on one side and a receiving fluid on the other. Samples are taken from the receiving fluid over several hours to determine if breakthrough has occurred.

It is important to note that chemotherapy glove clearance [510 (k)] from the government is based only on the resistance to permeation. It is up to each facility to review guidelines published by professional associations in establishing their own chemotherapy and general hazardous drug (HD) glove usage policies.

Antiseptic, Disinfectant and Liquid Sterilant Penetration Testing Gloved hands may routinely come in contact with numerous antiseptics, disinfectants and/or liquid
sterilants. Thus, it is important to know the quality of chemical protection the glove provides.
Although no requirements exist for gloves, some manufacturers may choose to use the ASTM F739 method to evaluate the resistance of their gloves to specific chemicals. Information regarding chemical permeation must be requested directly from the manufacturer. Facilities will vary, of course, but frequently used chemicals include gluteral dehyde, is opropyl alcohol and formalin.

There are general characteristics of glove degradation that may indicate a breakdown in the glove barrier integrity. It is important to recognize these general indicators to help ensure the selection and maintenance of optimal glove protection. These indicators of degradation include:
• Hardening or embrittlement
• Loss of strength
• Softening (may see extending of fingertips)
• Loss of tear resistance
• Tackiness

• Loss of elasticity
• Cracking