Are These Gloves Food Safe?

Are these gloves food safe? FDA regulations

In food handling and food processing, gloves serve the dual purpose of protecting the worker and protecting the food from human pathogens such as bacteria and viruses. These gloves, however, are made from a wide range of natural and synthetic chemicals. It is important that the chemicals in the glove material do not inadvertently migrate to the food and become an unintended food additive.  

In the USA, the Food and Drug Administration (FDA) regulates three classes of food additives. Direct food additives, such as food coloring, are added to and remain in the food. Secondary direct food additives are added to the food during processing, but are removed from the final food product. Indirect food additives are substances that come into contact with the food but are not intended to be added to the food. These additives could come from anything the food comes into contact with, including equipment, packaging, and gloves.

FDA 21 CFR Part 177.2600

To ensure gloves will not transfer harmful chemicals, colors, odors or tastes to food, they must comply with FDA 21 CFR Part 177.2600 – Rubber articles intended for repeated use. This Code of Federal Regulations (CFR) lists the permitted materials and chemicals that can come into contact with food. This includes the elastomers, such as acrylonitrile-butadiene copolymer (nitrile,) chloroprene polymers, and natural rubber (latex.) It also details acceptable accelerants, activators, antioxidants, plasticizers, fillers and colorants used in manufacturing these rubber articles.

The code stipulates extractable limits for both fatty and aqueous (watery) foods. Overall migration – the total of the substances that can migrate – is tested, measured and reported as milligrams per square inch.

The overall migration limit (OML) for fatty foods is 20 milligrams per square inch at 7 hours, with no more than one additional milligram between 7 and 9 hours.

The OML for aqueous foods is 175 milligrams per square inch at 7 hours, with no more than 4 milligrams per square inch between 7 and 9 hours.

Using RoyalTouch300 Nitrile Exam Gloves as an example, overall migration can be quite low compared to the requirement.

Extraction Conditions Overall Migration for
Glove Sample (mg/in2)
21 CFR Part 177.2600
Requirement
Inferred Result
Distilled water at reflux temperature for 7 hours ND(<0.5) 20 Comply
Distilled water at reflux temperature for 9 hours (additional 2 hours from initial 7 hours extraction) ND(<0.5) 1 Comply
n-Hexane at reflux temperature for 7 hours 0.6 175 Comply
n-Hexane at reflux temperature for 9 hours (additional 2 hours from initial 7 hours extraction) ND(<0.5) 4 Comply

 

With over 200 glove types on the market – considering differences in material composition, thickness, internal and external treatments, powder, and modulus – it is important to determine if your selected glove is suitable for food contact.

While most examination gloves would meet this FDA regulation, ASTM standards for exam gloves are more about barrier resistance and durability, and do not directly address overall migration of chemicals.

To help you verify that a glove complies with CFR 21, the glove company should be able to supply a FDA letter of guarantee or a document with the overall migration test results.

Request Free Sample of RoyalTouch300 Food Safe Gloves

Exam Gloves “Manufactured in Malaysia” – How Safe?

How safe are exam gloves manufactured in Malaysia?

Most of the exam gloves available here in the U.S. are manufactured and imported from other countries, such as Malaysia.  How can you be sure that you are getting a safe, reliable product?  Fortunately, manufacturers, importers and the government are working hard to ensure your safety.

FDA Regulation

Patient examination gloves are a class I medical device and subject to the controls of the FDA.  This class of disposable gloves is meant for medical purposes to protect the wearer’s hand and to prevent contamination between the patient and the wearer.   The gloves can be made from latex, vinyl or a polymer other than vinyl, such as nitrile or polyurethane.

To meet the FDA requirements for patient examination gloves, the product must meet a number of standards, including the following:

ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves
ASTM D3578 Standard Test Method for Rubber Examination Gloves

Additionally, there are specific rules for labeling.  A powder-free nitrile exam glove that meets FDA requirements will have the words “powder-free nitrile examination glove” on the box.   Disposable latex, nitrile or vinyl gloves that do not include the word “examination” on the box are for general purpose use, and are not safe to use in medical, dental or other health care settings.

Ambiguous terms such as “extra-thick” or “super-sensitive” are not allowed on the box because they could be misleading.  The term “hypoallergenic” is strongly discouraged, as it cannot be scientifically defined.  Only factual and definitive statements are allowed.

Quality System Regulation

Medical glove manufacturers are required to meet the Quality System regulation for medical devices – 21 CFR part 820.  This regulation states that “each manufacturer must establish and maintain a quality system that is appropriate for the specific medical device . . . manufactured.”

Malaysian manufacturers run state-of-the-art facilities.  There are process controls for every single stage of manufacturing, from compounding , dipping and curing, to drying, powder removal and rinsing.  With proper process and quality controls, manufacturers are able to control or eliminate defects in gloves, such as pinholes, as well as control or minimize undesirable chemical residues.

Compliance Inspections

To ensure compliance, the FDA sends auditors to manufacturers, including foreign manufacturing sites, to perform factory inspections.  They review the facility, operations, environment and records to determine the level of compliance with the Quality System regulation.

When a glove shipment arrives at a US port, the FDA may hold the shipment and collect a sample of the gloves for testing.  If the sample fails, the FDA then detains all lots of the same glove type in the shipment, effectively removing them from the supply chain.  They may also hold shipments of gloves that have been misbranded with unsubstantiated claims, or are not labeled properly.

The relationship between glove manufacturers, importers and the FDA helps ensure that the exam gloves you wear will do the job they were meant to do – prevent contamination and keep you safe.  So the next time you see “Manufactured in Malaysia” on a box of gloves or product literature, you can be confident you are getting a quality product.

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Powdered and Latex Medical Gloves to Be Banned?

Almost everyone in the glove industry heard the news back in April. Public Citizen, a consumer advocacy group, petitioned the FDA to take drastic steps to protect individuals with latex allergies. They called for a complete ban on all cornstarch powdered medical gloves, as well as a ban on all natural latex rubber medical gloves.

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FDA Soon to Require Warning Label on Powdered Medical Gloves


UPDATE:  The “Draft Guidance for Industry and FDA Staff – Recommended Warning for Surgeon’s Gloves and Patient Examination Gloves that Use Powder,” referenced in this post, was withdrawn on April 27, 2015.


The problems associated with powdered medical gloves are well documented. The FDA first issued a Medical Glove Powder Report back in 1997, warning of adverse health events that included dyspnea, respiratory problems, allergic reactions, and granuloma formations.

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