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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Compounding Pharmacies – Sterile Gloves and Fingertip Sampling Required

The fungal meningitis outbreak caused by contaminated steroid medications made by New England Compounding Center in Framingham (NECC), Mass. has brought about a flurry of articles and blog posts calling for tighter regulations and direct FDA oversight of compounding pharmacies.  Some of the articles make it appear that compounding pharmacies are nothing more than renegade miniature drug companies making HRT medications and other controversial drugs.

While there appear to be some pharmacies that need to be reined in, most compounding pharmacies exist in hospitals.  These pharmacies normally prepare a medication to order, for a specific patient from a prescription.  Independent compounding pharmacies contract with hospitals and clinics to fill their compounded medication needs.  Many feel that NECC crossed the line from a traditional compounding pharmacy to a drug manufacturer with interstate commerce.

At the end of all of the debating and legal haranguing (which won’t end soon,) the primary issue is safety.  So what regulations are in place to help ensure that sterile medications from compounding pharmacies are safe?

USP 797

The U.S. Pharmacopoeia (USP) issued the first practice standards for compounding pharmacies in the U.S. back in 2004.  Chapter <797>, Pharmaceutical Compounding – Sterile Preparations, commonly referred to as USP 797, was updated in 2008, and is designed to cut down on infections transmitted to patients through “compounded sterile preparations” (CSPs).

Compliance

After eight years, how are compounding pharmacies doing on compliance?  A nationwide Compliance Study conducted in 2011 and updated in 2012 shows that although the chapter has done much to improve the quality of CSPs, there is also much room for improvement.

Here is one example, a test called Gloved Fingertip/Thumb Sampling, designed to demonstrate that the compounder can properly don PPE and sterile gloves, and prepare a medication without contamination:

“In 2011, only 30% of hospitals complied with the requirement for all compounding personnel (including supervising pharmacists) to successfully complete at least three gloved fingertip/thumb sampling procedures (success is 0 CFUs for both hands) before being allowed to compound CSPs. This requirement is designed to verify that compounding personnel can properly don sterile gloves without contaminating them . . . in 2012, compliance with this requirement has increased to 36%.” – 2012 USP <797> Compliance Survey

This is certainly a cause for concern.  Skin cells are shed from the human body at a rate of a million or more per hour and these skin particles are laden with microorganisms.  Gloved Fingertip/Thumb Sampling measures both the microorganisms and particles in the controlled compounding environment and on surfaces like gloves.  It reveals poor aseptic technique or improper disinfection of sterile gloves.

Sterile gloves are a requirement in preparing CSPs.  Non-sterile exam gloves treated with 70% IPA have not been proven adequate in preventing contamination.  Eric Kastango, MBA, RPh, FASHP, president and CEO of Clinical IQ, LLC, a health care consulting firm in Madison, N.J., and a member of the 2010-2015 USP Compounding Expert Committee, states “The decision the USP committee made in requiring sterile gloves over nonsterile gloves is that you start with a pair of gloves with zero microbial bioburden and that it’s a very inexpensive way to maintain a state of control and prevent the risk for contamination and infections. It’s critical to make sure we’re giving patients the safest, best opportunity to have the lowest risk for contamination from compounded sterile preparations.”

Enforcement

So who enforces USP 797?  While the FDA regulates the ingredients, it does not regulate practitioners.  Compounders are regulated by a patchwork of state oversight, including Joint Commission and state pharmacy boards.  In general, the FDA has deferred to states in regard to USP 797, but it can investigate allegations of contaminated drugs, as in the case of NECC.

Compounding pharmacies can be sure that they will be coming under increased scrutiny and regulation.  Compliance with USP 797, which requires sterile gloves and a host of other safety standards is imperative.   By doing so, they can ensure the highest quality compounding environment and deliver ever-safer medications to the public.

Resources:

Summary of USP 797 for Compounding Sterile Preparations

 

 

What do you think?  Are compounding pharmacies doing enough to comply with USP 797?  Share your comments below.

Disposable Glove Quality Testing

The FDA sets high standards to ensure the disposable gloves you purchase here in the U.S. perform as expected and provide an adequate barrier for their intended use.  To meet these standards, glove manufacturers have tight quality controls and manufacture gloves according to ASTM specifications and testing requirements.

A key quality measurement that glove manufacturers publish on glove boxes, bags and product literature is AQL, or Acceptable Quality Level.

Stated as a percentage, the AQL is a statistical measurement of the quality of the gloves.  An AQL of 2.5% means that statistically, only 2.5 gloves for every hundred gloves will fail a quality test.

How AQL is Determined

Let’s say a glove manufacturer produces 10,000 gloves from the same material, settings and processes.  Two hundred gloves would be pulled randomly from the line, throughout the batch, to be tested.  To meet an AQL of 2.5%, no more than 10 gloves can fail the quality tests.  If more than 10 gloves fail, the entire batch fails, and each glove must be tested individually for quality, or else the whole batch is discarded.  An AQL of 1.5% would mean that no more than 7 gloves could fail.

ASTM D5151 Test for Detection of Holes in Medical Gloves

Disposable gloves are subjected to numerous ASTM tests throughout the manufacturing process.  One test that medical and cleanroom gloves have in common is a test for pinholes.

ASTM D5151 is the Standard Test Method for Detection of Holes in Medical Gloves, often referred to as the “watertight” test or “water leak” test.   In this test, the gloves are each filled with 1000 ml of water at room temperature, secured at the cuff and hung vertically for two minutes to check for pinholes.  If water does not leak from the glove, it gets a “pass.”

The current FDA mandated maximum AQL for examination and cleanroom gloves on this test is 2.5%, down from the previous 4.0% prior to December 2008.  Some gloves, however, are manufactured and tested to meet the lower AQL of 1.5% required for surgical gloves.  This means higher quality and fewer pinholes.

Disposable Gloves Reduce Risk of Foodborne Illness

Foodborne illness.  No restaurant operator wants those words associated with their establishment.  To ensure their food is safe, many hours are devoted to employee education and ongoing training.  Hand hygiene and disposable gloves are an important part of safe food handling.

Restroom Germs and Cross-Contamination

A critical component to safe food handling is proper gloving and hand hygiene. “Restroom germs” such as E. coli, Staphylococcus, Giardia, Hepatitis A, Norovirus, and Shigella can be transmitted from hands to food.  Cross-contamination can also occur, transferring pathogens such as salmonella.  Restaurants offering gluten-free foods have the added concern of  gluten being accidentally transferred.

The problem of foodborne illness has real consequences – both for customers and food service establishments.  In 2009, a McDonald’s location in Illinois was linked to a hepatitis A outbreak that resulted in a class-action lawsuit.  And in New York City alone, dining out was linked to 3,500 hospitalizations in 2008 for food-borne illnesses and some 1,300 cases of salmonella.

But even if employees were always diligent about washing their hands, hand washing alone is not enough to prevent food-borne illness.  Routine hand washing does not remove all bacteria, and it only takes a small amount to make someone sick.  An additional barrier, such as a disposable glove, is needed.

FDA Food Code 2009

To help make food safer, the Food and Drug Administration (FDA) released an updated Food Code in 2009.  Here are some of the food handling rules:

  • Employees may not touch ready-to-eat foods with bare hands, except when washing fruits and vegetables, or when otherwise approved.  They must use a barrier, such as deli tissue, spatulas, tongs or gloves.
  • Wearing gloves is not a substitute for proper hand washing. Gloves can fail, and allow bacteria and viruses through, so employees must wash their hands before donning gloves to work with food.
  • Gloves should be changed often.  Gloves should be changed when they become damaged or soiled, after 4 hours of wear, or after handling raw foods.
  • Glove should be worn for a single task.  A food service employee should never handle money, take out the trash or perform other tasks and return to handling ready-to-eat food without changing their gloves.

Gluten-Free Food Handling

Restaurants such as Subway that are starting to offer gluten-free foods are giving special attention to hand hygiene and proper gloving and food handling.  And rightly so.  An employee that handles regular gluten-containing bread and then handles gluten-free bead without changing gloves has just cross-contaminated the food.  While this may not affect a customer with a non-celiac gluten intolerance, it spells real trouble for a customer with true Celiac Disease.

Glove Selection Considerations

Restaurant operators or managers selecting gloves for employees are necessarily concerned with cost.  But the cheapest gloves may not be the best choice.  Considering the following criteria will help ensure the right glove is purchased for the right job.

  • Proper Fit – For the safety of the employee, properly fitted gloves are essential.  Gloves that are too loose can result in serious bodily injury.  Glove that are too tight lead to hand strain.
  • Proper Material – Consider the dexterity needed for the tasks the employee is performing.  While a poly glove may be suitable for assembling a sandwich, a more form fitting nitrile glove is better suited for tasks like slicing and chopping.
  • Comfort – A comfortable glove that provides adequate grip and tactile sense will increase employee compliance and safety.
  • Allergens – Allergens and chemical sensitivities should be considered.  Employees concerned about latex sensitization should be offered a non-latex alternative, like nitrile gloves.  Please note that some individuals may be sensitive to the chemicals commonly found in non-latex gloves.  If this is the case, accelerator-free nitrile gloves like FreeStyle1100 are now available.

By carefully educating employees about hand hygiene and providing gloves that are suitable to the task and comfortable to wear, restaurant operators can be confident they are doing their part to reduce the risk of food-borne illness.

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.

Read morePowdered and Latex Medical Gloves to Be Banned?

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.

Read moreFDA Soon to Require Warning Label on Powdered Medical Gloves

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