Do FDA Compliant Gloves Protect Our Food?

A UK investigation showed that hands can carry a variety of gut and faecal material. The investigation found traces of faeces on every sample of McDonald’s touchscreens swabbed.

One branch was found to have Staphylococcus spp., a bacterium that can cause blood poisoning and toxic shock syndrome; and another, Listeria, which can cause listeriosis leading to miscarriages and stillbirths in pregnant women. Three-quarters of the screens swabbed showed traces of the bacteria Proteus, which can be found in human and animal faeces and can cause urinary tract infections.

A USDA study explains, “consumers are failing to properly clean their hands 97 per cent of the time. Rushed handwashing can lead to cross-contamination of food and other surfaces, resulting in foodborne illness.”

The U.S. Food & Drug Administration (FDA) Food Code represents current guidelines for food safety and stipulates that food handlers should not handle ready-to-eat food with their bare hands, but rather by using utensils such as single-use gloves. The code also notes that gloves, when misused, may themselves serve as a source of cross-contamination, and emphasises the importance of observing glove use during food preparation activities to reduce risk factors.

Even though food establishments have signage to reinforce correct hand-washing procedures for both employees and consumers, studies clearly show this may not be happening. Let’s take a look at hand hygiene and gloves in more detail, and how our food can and does become contaminated.

 

HUMAN SKIN MICROBES

The human skin is a rich environment for microbes consisting of around 1,000 species (Grice et al. 2009). The skin surface of human hands contains up to 10 million microorganisms (Price 1938), most of which are resident species, some with the potential to cause disease, such as Staphylococcus spp. or Streptococcus spp.

True problems occur when, due to poor hand skin health, transient organisms can become resident colonisers (Price 1938; Michaels et al. 2004). When this occurs, combined with a glove puncture, what has been described as a liquid bridge of microbial contamination can flow to contact surfaces (Cole & Bernard 1964; Fox 1971).

Additionally, even where gloves are used as a barrier, the FDA clearly states that proper hand washing remains essential, as gloves or other utensils can become vehicles for transferring microbes to food if hands are not washed thoroughly before donning gloves.

The FDA Food Code specifies that hands must be washed “before donning gloves to initiate a task that involves working with food.”

 

GLOVE JUICE

Hands contain over 400 sweat glands per square centimetre. When wearing disposable gloves, all the moisture created by thousands of sweat glands is trapped, where oxygen levels plummet, and skin maceration creates high microbial counts.

The nail region, the most difficult to get pristinely clean, contains the richest microbial flora. Glove occlusion decreases the generation time of microflora and increases contamination from whatever was on the hand or under the fingernails before the gloves were donned. This warm, damp environment, often called “glove juice”, accelerates microbial growth on skin surfaces and around nail beds.

 

DO FDA COMPLIANT GLOVES PROTECT OUR FOOD?

We often hear “My gloves have FDA compliance for food handling”; this does not make them food safe. These gloves have no acceptable quality level (AQL) requirements; AQL refers to a quality standard for measuring pinhole defects. So, with no testing required for pinhole defects, disposable gloves can be FDA (21 CFR 177) compliant for food handling. Knowing a glove’s AQL is essential in determining its level of food safety.

Scientific studies show up to 50% of vinyl gloves contain holes, and up to 96% of glove punctures go undetected by glove wearers. Selecting the correct type of food safety glove is essential.

Studies have also shown that up to 18,000 Staphylococci can pass through a single glove hole during a 20-minute period, even though the hands had been scrubbed for 10 minutes before gloving (Guzewich & Ross, 1999).

The FDA additionally categorises gloves as “utensils” under the Food Code, meaning they must meet requirements for utensil construction, good repair, cleaning, and storage. The Code notes:

“Pathogens can be transferred to food from utensils that have been stored on surfaces which have not been cleaned and sanitized.”

This means that where gloves are stored and what surfaces they contact directly affect food safety, further increasing the potential for cross-contamination when gloves are not handled or stored correctly.

Given the microbes on our hand skin, combined with glove juice, poor hand-washing, gloves with pinhole defects, and incorrect glove storage and use, the perfect storm of food contamination can occur.

 

WHAT IS THE GLOVE MADE OF? - PART 177

Food contact gloves are certified under FDA Title 21 CFR Part 177 (CFR), which states that the components of the glove comply with the FDA regulations and the gloves consist of “Substances generally recognised as safe for use in food or food packaging.”

However, the quality and safety of disposable gloves is limited to Letters of Compliance and Guarantee on the general make and model of the glove submitted for testing, not necessarily the glove you are holding in your hand.

There are a few controls required for glove manufacturing relating to the reliability of raw materials, manufacturing processes, and factory compliance. The opportunity also exists for deliberate or accidental contamination within the process.

It therefore becomes possible for a glove manufacturer to achieve FDA Title 21 CFR Part 177 certification for a glove, then alter manufacturing practices, hygiene practices, and raw material content to save costs.

Are you certain the manufacturer of your disposable gloves is providing product consistency and complying with FDA requirements?

HOW IS THE GLOVE USED AND IS IT SATISFACTORY FOR THAT USE - PART 110

What is often overlooked are the complementary regulations also listed under FDA Title 21 Part 110 – Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. In particular:

110.10 Personnel (5):
“Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material.”

The Food Code further requires that:

• Single-use gloves must be used for only one task (for example, RTE foods or raw animal foods).
  

• Gloves must be discarded when damaged, soiled, when interruptions occur in operations, or when soil or contaminants enter the inside of the glove.
  

• Bare-hand contact with exposed, ready-to-eat food is prohibited, and suitable utensils, including gloves, are required as a final protective barrier.

 

SANITARY

“Sanitary" is not defined within the CFR, but the word "sanitise" is. “Sanitise means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.”

Simply put, the surface needs to be cleared of germs and other food contaminants. Do gloves meet the same standards as other sanitised surfaces?!

A well-regarded study conducted in New Zealand under hospital conditions reported the following disturbing information on commercially available disposable nitrile gloves:

“Environmental bacteria, particularly Bacillus species, were present on 31/38 (81.6%) of disposable glove samples.”

That is, over 80% of the gloves on the opening of the box were contaminated with bacteria. This may not be of danger, but is an implication of the sanitary conditions (or lack thereof) in the offshore glove production and packing facility.

 

IMPERMEABLE 

FDA rules state, “the gloves should be of an impermeable material”. The term “impermeable” is not defined within the CFR.

In many cases of US food preparation, processing, and service, vinyl gloves remain the predominant choice purely because of cost. However, many international studies now demonstrate the variable permeability of vinyl gloves, particularly regarding bacteria and virus penetration:

• “...after manipulation intended to simulate in-use conditions, vinyl gloves failed 12% to 61% of the time.” (A Rego 1999)
  

• “Polyethylene and polyvinyl chloride [vinyl] gloves had failure rates of 40% and 22%, respectively. Following exposure to 70% ethanol, failure rates increased to 94% and 56%.” (R C Klein 1990)
  

Many other studies confirm these findings, showing vinyl gloves to have significant permeability under normal working conditions.

To comply fully with FDA Title 21 Part 110, food handling, processing, and service facilities must consider:

1. The origin of the gloves, ensuring they come from clean and inspected factories, and
   

2. The type and quality of glove selected, with the only clear choice being a high-quality nitrile glove suited to the application.
   

 

CHOOSING A PROVIDER WHOSE GLOVES ARE PROVEN SAFE

Choosing a certified food-safe glove is essential to protect your product. Eagle’s multi-stage third-party glove testing program, Delta Zero™, has been initiated to further assure that our food contact gloves, used in RTE settings with no kill step, remain safe from pathogen transfer.

With 15–18% of food-borne illness outbreaks implicating disposable glove cross-contamination (CDC et al.), selecting and correctly using the right glove is critical. 

Contact us now to discuss how Eagle can enhance your food safety programs or to experience the quality and safety difference of our gloves for yourself.