Overview

Exam gloves are considered essential personal protective equipment (PPE) for health care workers. They provide a protective barrier for hands and fingers against infectious agents that can be harmful if they make direct contact with skin. COVID-19 — along with its related complications — has increased the need for gloves due to the rapid rise in the number of patient hospitalizations.1 As a result, specific conservation strategies to manage the limited supply of exam gloves are vital.

Types of exam gloves

The Occupational Safety and Health Administration (OSHA) requires that employees be protected from workplace hazards to avoid injuries.2 Thus, it is essential for health care providers to have access to PPE such as gowns, gloves, eye and facial protection (e.g., goggles, face shields and helmets), and respirators. PPE provides a protective barrier for health care workers and helps to minimize their exposure to potential risks while providing care to patients.

Exam gloves protect the hands against blood, bodily fluids, hazardous drugs or infectious diseases. Many different types of gloves are available based on indication for use. According to OSHA, the following factors should be reviewed prior to making a glove selection2:

  • Type of chemicals handled
  • Nature of contact (e.g., total immersion or splash)
  • Duration of contact
  • Area requiring protection (i.e., hand only, forearm or whole arm)
  • Grip requirements (i.e., dry, wet or oily)
  • Thermal protection
  • Size and comfort
  • Abrasion or resistance requirements

Table 1 provides a condensed review of the chemical and liquid resistance of various types of gloves used in health care, based on material type, along with the type of protection provided to the user. Chemical-resistant gloves such as natural rubber, neoprene, nitrile, butyl or plastic polyvinyl (vinyl) can be blended or laminated. These additional layers and thickness provide increased performance and chemical resistance, although finger grip and dexterity may be compromised.2

Table 1. Types of chemical- and liquid-resistant gloves

Type of glove Materials and characteristics Considerations
Natural (latex) rubber
  • Comfortable
  • Strong tensile strength, elasticity and temperature resistance
  • Protects against most water solutions of acids, alkalis, salts and ketones
  • Latex gloves have caused allergic reactions and may not be appropriate for all health care workers
  • Hypoallergenic gloves, glove liners and powderless gloves are alternatives
Neoprene
  • Made from synthetic rubber
  • Provides good pliability, finger dexterity, high density and tear resistance
  • Protects against hydraulic fluids, gasoline, alcohols, organic acids and alkalis
  • Generally, gloves with chemical and wear resistance properties are superior to those made of natural rubber
Nitrile
  • Made of a copolymer
  • Protects against chlorinated solvents, oils, greases, acids, caustics and alcohols
  • Provides dexterity and sensitivity
  • Provides prolonged protection compared to other gloves
  • Not recommended for use with strong oxidizing agents, aromatic solvents, ketones and acetates
Butyl
  • Made from synthetic rubber
  • Protects against a wide variety of chemicals such as peroxide, rocket fuels, highly corrosive acids (e.g., nitric, sulfuric, hydrofluoric and red-fuming nitric), strong bases, alcohols, aldehydes, ketones, esters and nitro compounds
  • Does not perform well with aliphatic and aromatic hydrocarbons, nor halogenated solvents
Polyvinyl chloride/vinyl
  • Latex alternative
  • Commonly referred to as vinyl
  • Lacks elasticity, resulting in loose-fitting gloves
  • Less expensive
  • Lowest puncture permeability and chemical resistance
Powdered
  • Cornstarch is commonly used to reduce sweat
  • Can be purchased in latex, nitrile and polyvinyl
  • Banned by the FDA due to risk of airway inflammation

Data derived from Occupational Safety and Health Administration.2
Abbreviation: FDA = U.S. Food & Drug Administration.

Due to the risk of patients and health care providers having latex allergies or developing latex sensitivities, the use of latex gloves in the health care industry is decreasing, although they continue to be an option for hand protection. Approximately 8%-12% of health care workers are latex sensitive3; symptoms vary from contact dermatitis to asthma to  systemic shock. Anyone with a latex allergy or latex sensitivity should use an alternative such as hypoallergenic gloves, glove liners or powderless gloves.

In 2016, the U.S. Food & Drug Administration (FDA) banned powdered gloves due to the substantial risk of harm to health care providers and patients.4 Powdered gloves have been linked to severe airway inflammation and hypersensitivity reactions when internal body tissue is exposed to the powder.4 In addition, powder particles have the potential to cause tissue to form around the particles (granulomas) or cause scar tissue formation (adhesions), leading to surgical intervention.4

The American Society for Testing and Materials (ASTM) evaluates the performance and safety of exam gloves through specific testing procedures, and has created standards for exam gloves used in health care settings. Additional information about ASTM’s test procedures and recommended standards can be found on its website.5

Surge capacity

The Centers for Disease Control and Prevention (CDC) has been tracking the number of COVID-19 cases in the U.S. with assistance from state, local and territorial health departments,6 with a weekly update available on its website.1 The goals of the surveillance are to:

  • Monitor spread and intensity of COVID-19 disease in the U.S.
  • Understand disease severity and the spectrum of illness
  • Understand risk factors for severe disease and transmission
  • Monitor changes in the virus that causes COVID-19
  • Estimate disease burden
  • Produce data for forecasting COVID-19 spread and impact

The CDC’s monitoring of COVID-19 also enables it to identify surges or significant increases in patient visits in outpatient centers, emergency departments and hospitals. The increase of patients needing medical care also means health care providers need additional PPE — including gloves — to provide safe and effective care.

The CDC refers to surge capacity as a facility’s ability to manage a sudden increase in patient volume that severely challenges or exceeds the present capacity.7 This increase forces health care facilities to find unique ways to conserve supplies to meet patient needs. The CDC created the Personal Protective Equipment (PPE) Burn Rate Calculator to help facilities prepare and prioritize measures to conserve these supplies.8 The calculator can be used to optimize the use of gowns, gloves, surgical masks, respirators and face shields by calculating the average consumption rate, and estimates how long the remaining supply of PPE will last.8 The tool can also help determine which strategy to use to conserve PPE supplies for continuation of patient care.8

The CDC has identified three strategies to describe surge capacity along with conservation measures to extend the life of PPE supplies: conventional capacity, contingency capacity and crisis capacity. Each measure is meant to be used sequentially, with a facility’s standard protocol resuming when the PPE supply is replenished. Prior to implementing contingency and crisis strategies, the CDC recommends that facilities:

  • Understand their current PPE inventory and supply chain
  • Understand their PPE utilization rate8
  • Communicate with local health care coalitions and federal, state and local public health partners (e.g., public health emergency preparedness and response staff) to identify additional supplies
  • Implement conventional capacity measures if they haven’t already done so
  • Provide health care providers with required education and training, including having them demonstrate competency donning and doffing any PPE ensemble that is used to perform job responsibilities, such as the provision of patient care

Conventional capacity strategies

Conventional capacity measures are standard protocols already established for infection prevention that consist of engineering, administrative and PPE controls.9 Double gloving is not recommended by the CDC when caring for a patient with suspected or confirmed COVID-19 and patient care should continue as normal. The CDC also recommends the following actions while using conventional strategies:

  • Continue using approved disposable medical gloves in accordance with standard10 and transmission-based11 precautions in health care settings and when indicated for other exposures such as handling cleaning chemicals
  • Reinforce indications and recommended practices for nonsterile disposable glove use
  • Prioritize sterile gloves for surgical and other sterile procedures
  • Prioritize medical gloves for health care providers handling chemotherapy agents (chemotherapy gloves) and other hazardous drugs
  • Remind health care providers about indications that require gloves, as well as common care situations when gloves may not be needed

Contingency capacity strategies

Contingency capacity strategies should be used in anticipation of an expected PPE shortage and after conventional capacity measures are no longer suited to the patient load.9 This measure should be implemented in cases of uncertainty regarding future PPE supply availability even if current utilization is being met. The CDC recommends that facilities:

  • Reduce the length of stay for medically stable patients with COVID-19
  • Selectively cancel elective and nonurgent procedures and appointments where gloves are routinely used by health care providers
  • Use gloves beyond their manufacturer-designated shelf life for training activities
  • Use gloves conforming to other U.S. and international standards; additional information about international standards can be found on the CDC’s gloves webpage7

Crisis capacity strategies

Crisis capacity strategies should only be implemented after conventional and contingency capacity strategies have been reviewed because they do not align with U.S. standards of care.9 These strategies should be applied when the PPE supply will not meet the needs of the facility, and include the following:

  • Cancel all elective and nonemergent procedures for which gloves are typically used
  • Use gloves past their manufacturer-designated shelf life for health care delivery
  • Prioritize the use of nonsterile disposable gloves
  • Consider non-health care glove alternatives such as food service or industrial chemical-resistant gloves
  • Extend the use of disposable medical gloves, including wearing gloves without changing into a new pair between patients

The CDC recommends discarding medical gloves when:

  • Visible soiling or contamination due to blood, respiratory or nasal secretions, or other bodily fluids is apparent
  • Any signs of damage (e.g., holes, rips or tearing) or degradation are observed
  • A maximum of four hours of continuous use has been reached

Previously removed gloves should not be worn again, as the risk of tearing and contamination increases. Additional information about the extended use of disposable gloves can be found on the CDC’s website.7

Government guidance addressing the U.S. exam glove shortage

In March 2020, the FDA issued guidance to address the shortage related to the increased use of gloves due to COVID-19. The Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency was created to help expand the availability of gloves in the U.S.12 Gloves are identified as a device if they are expected to be used for medical purposes, such as diagnosing a disease or other conditions or in curing, mitigating, treating or preventing disease. The FDA uses the following criteria when evaluating whether products are intended for medical use:

  • Gloves are labeled or otherwise intended for use by a health care professional
  • Gloves are labeled or otherwise intended for use in a health care facility or environment
  • Gloves include any drugs, biologics, or antimicrobial or antiviral agents

Gloves intended to be used by the general public and for nonmedical purposes are not considered devices and therefore authorization is not required by the FDA. Manufacturers, importers and distributors of nonmedical gloves may market their products without receiving prior approval from the FDA.

Patient exam gloves are subject to premarket notification requirements because they are a Class I device intended for medical use under section 510(k) of the Federal Food, Drug, and Cosmetic Act.12,13 A 510(k) is a premarket submission made by the submitter or manufacturer that states their device is substantially equivalent to a legally marketed device with supporting evidence. The submitter can only market their product in the U.S. when they have received an approval that states their product is substantially equivalent to a legally marketed device. This process can take up to 90 days and is based on the supporting evidence submitted to the FDA. The FDA provides additional information for evaluating substantial equivalence for the 510(k) program on its website.14

The FDA is aware of the shortage of gloves due to increased demand. As a result, it will not object to the distribution and use of patient exam gloves where the gloves do not create an undue risk during the COVID-19 public health emergency. The FDA states patient exam gloves do not create an undue risk when:

  • The gloves include labeling that:
    • Accurately describes the product as an “unpowdered glove” (as opposed to a “surgeon’s glove”).
    • Accurately describes the product’s sterility status (e.g., nonsterile).
    • Does not claim that the product is latex-free or otherwise free of a specific material.
    • Includes a list of the body contacting materials.
    • Includes recommendations and general statements that would reduce the risk of use. Examples include:
      • A statement that the gloves have not been cleared by FDA
      • A recommendation against using when FDA-cleared gloves are available
      • A recommendation against using in surgical settings
  • The product is not intended for any use that would create an undue risk. For example:
  • The labeling does not include uses with chemotherapy drugs, fentanyl and other opioids; for allergy or dermatitis prevention; for antimicrobial or antiviral protection; or for infection prevention or reduction

Additional resources

Vizient contract information

Contract no. Supplier
MS4551 Novaplus®/Cardinal Health
MS4552 O&M Halyard
MS4554 Medline Industries
MS4555 Sempermed USA
MS4556 Tronex International
MS4557 Innovative Healthcare Corp.

References

  1. Key updates for week 45, ending November 7, 2020. Centers for Disease Control and Prevention. Updated November 13, 2020. Accessed November 13, 2020.
  2. Personal protective equipment. Occupational Safety and Health Administration. Accessed November 13, 2020.
  3. Latex allergy. Occupational Safety and Health Administration. Accessed November 13, 2020.
  4. Banned devices; powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. Federal Register. December 19, 2016. Accessed November 13, 2020.
  5. ASTM standards and COVID-19. ASTM International. Accessed November 13, 2020.
  6. Purpose and methods. Centers for Disease Control and Prevention. Updated August 28, 2020. Accessed November 13, 2020.
  7. Strategies for optimizing the supply of disposable medical gloves. Centers for Disease Control and Prevention. Updated October 27, 2020. Accessed November 13, 2020.
  8. Personal Protective Equipment (PPE) Burn Rate Calculator. Centers for Disease Control and Prevention. Updated April 7, 2020. Accessed November 13, 2020.
  9. Optimizing supply of PPE and other equipment during shortages. Centers for Disease Control and Prevention. Updated July 16, 2020. Accessed November 13, 2020.
  10. Standard precautions for all patient care. Centers for Disease Control and Prevention. Accessed November 13, 2020.
  11. Transmission-based precautions. Centers for Disease Control and Prevention. Accessed November 13, 2020.
  12. Enforcement policy for gowns, other apparel, and gloves during the coronavirus disease (COVID-19) public health emergency. U.S. Food & Drug Administration. March 2020. Accessed November 13, 2020.
  13. Premarket notification 510(k). U.S. Food & Drug Administration. March 13, 2020. Accessed November 13, 2020.
  14. The 510(k) Program: Evaluating substantial equivalence in premarket notifications [510(k)]. U.S. Food & Drug Administration. July 2014. Accessed November 13, 2020.

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