Do Your Gloves Comply with FDA Recommendations and Requirements?

Here's what you need to know when sourcing your FDA-compliant food safety disposable gloves:

What is the glove made of? - Part 177

Food contact gloves are certified under FDA Title 21 CFR Part 177, which states that the components of the glove comply with the FDA regulations and the gloves consist of “Substances generally recognized 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 few controls required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance. Opportunity also exists for deliberate or accidental glove 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 to FDA requirements?

It is also worth noting that the terminology the USDA dictates is that the gloves are “accepted” not approved.

“Are you certain the manufacturer of your disposable gloves is providing product consistency, and complying to FDA requirements?”

How is the glove used and is it satisfactory for that use - Part 110

What are 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.”

Let's focus in on a couple of terms listed in that mandate.

Sanitary

What does this mean? "Sanitary" is not defined within the CFR, but the word "sanitize" is. “Sanitize 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 sanitized 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.” (Source: Bacterial contamination of unused, disposable non-sterile gloves on a hospital orthopaedic ward.)

That is - over 80% of gloves on 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.

One study showed that “over 80% of gloves on opening of the box were contaminated with bacteria.”

Note: Eagle Protect facilities are visited by Eagle personnel (not third party) regularly and an in-depth audit of facilities and process is performed under our Eagle Supplier Code of Conduct. Robust processes in these factories precludes the accumulation of environmental bacteria, which is generally enhanced by open storage or reduced glove cleaning at the later stages of the production cycle.

Impermeable

The term "impermeable" is also not defined within the CFR.

FDA Rules State: “The gloves should be of an impermeable material.”

In many cases of US food preparation, processing and service Vinyl Gloves are the predominant glove choice because of cost alone. There are now many international and US studies that provide proof of the variable permeability of Vinyl gloves – particularly regarding bacteria and virus penetration and permeation. Here are a couple of findings that support this notion:

“...after manipulation intended to simulate in-use conditions, vinyl gloves failed 12% to 61% of the time.”
(source: In-use barrier integrity of gloves: Latex and nitrile superior to vinyl)

"Polyethylene and polyvinyl chloride [Vinyl] gloves had failure rates of 40% and 22%, respectively. Following exposure to the common disinfectant, 70% ethanol, these failure rates increased to 94% and 56% for polyethylene and polyvinyl chloride gloves, respectively."
(source: Virus penetration of examination gloves.)

Many other studies confirm these findings of Vinyl gloves having variable and significant permeability to bacteria and virus under normal working conditions.

To fully comply with FDA Title 21 Part 110, food handling, processing and service facilities must firstly consider origin of the gloves, i.e. whether they have come from clean and inspected factories. Secondly, the type and quality of glove must also be considered... with the only clear choice being a Nitrile glove suited to the process being undertaken.

Choosing a Provider Whose Gloves are Proven Safe

Like any specialized field, when considering disposable gloves and other PPE, the food industry must turn to specialists within this field, such as Eagle Protect PBC. The New Zealand Food Industry turned to Eagle because with over 50% of the country’s GDP reliant on food exports, it had to be right!

This experience is now available to the US food sector, where food service businesses face increased regulation, observance, and potential damage from foodborne illness outbreak and recalls.

A range of Eagle nitrile products are single-sourced, Delta Zero ™ tested and lot verified to ensure they adhere to the highest level of consistent glove safety and performance. You receive the same product, same raw material, and same manufacturing process every time.