NFPA Standards | Medical Exam Gloves

Powder-free latex as well as non-latex gloves are now available to emergency medical technicians, paramedics, firefighters, and emergency department personnel. The use of powder-free, latex-free Nitrile gloves is especially important to emergency medical technicians, paramedics, firefighters, as well as emergency department personnel to avoid eliciting an allergic reaction in the latex sensitized patient. The majority of our emergency medical technicians, paramedics and firefighters are now wearing powder-free emergency medical examination gloves that comply with the stringent Codes and Standards established by the National Fıre Protection Association (NFPA).

The design and performance Standard as devised by the NFPA are to address protective clothing for emergency medical operations.;

The design and performance requirement of the emergency medical examination gloves were described in the NFPA 1999, Standard on Protective Clothing for Emergency Medical Operations, 1997 Edition. In September 2003, the emergency medical examination glove must meet the new design and performance requirements of emergency medical examination gloves discussed Submitted 24 May 2003; Revised 8 August 2003; Accepted 10 September 2003.

The NFPA Standard on Protective Clothing for Emergency Medical Operations, 2003 Edition design requirements emphasize that there must be at least five different sizes for emergency medical examination gloves. The performance requirements for emergency medical examination gloves include the following parameters: liquidtight integrity, biopenetration resistance, puncture resistance, soluble latex protein content, dexterity, and ultimate elongation and tensile strength.

Most firefighters, emergency medical technicians, paramedics, as well as emergency department personnel have made the transition to powder free gloves.

LATEX ALLERGENS

Latex allergens develop in some individuals after exposure to natural rubber latex (NRL), a substance composed of complex proteins from the rubber tree Hevea brasiliensis. NRL is composed of hundreds of proteins, including enzymes involved in the biosynthesis as well as lipids, nucleotides, and cofactors. The manufacturers use chemicals, such as accelerators and antioxidants to change the durability, stretch, and thermal stability of NRL. Two to three percent of the final glove product is natural protein. The ASTM D5712 Lowry test, the most commonly used test to identify total soluble proteins in latex gloves, has shown protein levels as high as 1000 µg/g in both powder-free and powdered examination and surgical gloves, while low protein gloves have tested less than 28 µg/g, or below detectable levels altogether.

Consequently, there is also an urgent need for the use of powder-free non-latex emergency medical examination gloves in patients sensitized to NRL.One attractive alternative to NRL has been gloves made from nitrile, a copolymer of butadiene and acrylonitrile. This NRL-free product has been used extensively by firefighters, emergency medical technicians, paramedics, as well as emergency department personnel. Nitrile exam gloves provide the most cost effective alternative to NRL, along with the best alternative for proper secure fit with tactile discrimination. Although nitrile properties differ significantly from NRL, including tensile, elongation and modulus properties, nitrile is most often recommended as the best NRL free glove as a barrier against pathogen penetration. Because of the latex allergy epidemic, our emergency medical technicians, paramedics, firefighters, as well as emergency department personnel are increasingly wearing NRL-free, powder-free Nitrile emergency medical examination gloves to avoid eliciting an allergic reaction in individuals suspected of having latex sensitivity.

With the newly published 2003 NFPA edition eliminating the requirement for modulus properties found in NRL, more non-NRL powder-free Nitrile emergency medical examination gloves now comply with the stringent codes and Standards established by the National Fıre Protection Association (NFPA), offering the Emergency Medical Services market an option to choose between both powder free latex and powder-free Nitrile compliant products.

The NFPA is an international, non-profit, membership organization designed to provide optimal fire and emergency services. Since it was established in 1896, NFPA has become a worldwide leader in fire suppression and safety, and emergency care.

The 2003 Standard was devised to identify protective garments, work gloves, emergency medical examination gloves, footwear and facewear designed to protect persons providing emergency medical care against exposure to liquid-borne pathogens during emergency medical operations. The Standard for emergency medical examination gloves has the following component: emergency medical design requirements, and emergency medical examination glove performance requirements.

Emergency medical examination gloves must be designated as single-use only. All compliant emergency medical examination gloves must be Class 1 Medical Devices and must meet the requirements of 21 CFR 880, “Medical Devices: Patient Examination Glove. In order to label or otherwise signify a emergency medical examination glove as being compliant with the requirements with this Standard, the manufacturer must provide emergency medical examination gloves in not less than five separate and distinct sizes. These sizes may vary considerably from extra-small (XS), small (S), medium (M), large (L),extra-large (XL), extra-extra-large (XXL), and even extra-extra-extra-large (XXXL). Emergency medical examination gloves may be manufactured in ambidextrous sizing. Emergency medical examination glove sizing must be consistent with EN 4555-2.

The emergency medical examination glove performance requirements need testing for liquidtight integrity, biopenetration resistance, puncture resistance,dexterity, latex protein level, tensile strength and elongation. Emergency Medical Examination Glove Testing Conditions Emergency medical examination gloves that are being tested for NFPA approval must meet strict requirements.;

To firefighters, emergency medical technicians, paramedics,and other emergency medical personnel, the biopenetration test might be considered the most important protective test, because it examines the ability of a pathogen to penetrate the emergency medical examination glove barrier. While the biopenetration test is representative of the material and formulation design as an effective barrier, the liquidtight integrity test should be considered equally as important, because this test when conducted on an ongoing basis, is representative of process quality. While an intact barrier, free from pinholes and holes, will not allow penetration, a glove possessing a pinhole defect will most certainly allow passage for viral transmission. Thus, ongoing lot test data for liquid tight integrity is the wearer’s best validation that the glove he selects is a trusted barrier. Additionally, the biopenetration test has especially stringent requirements, because any glove that allows viral passage will not be approved by the NFPA. The test is specifically designed to simulate penetration by hepatitis B (HBV), hepatitis C (HCV), and the Human Immunodeficiency Virus (HIV), in accordance with ASTM F 1671, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetrations by Blood-Borne Pathogens using Phi-X-174 Bacteriophage Penetration as a Test System.

When we abandoned the use of powdered emergency medical examination gloves, our emergency medical technicians, paramedics, firefighters, as well as emergency department personnel used only the powderfree emergency medical examination gloves. Their experience with this NFPA certified powder-free, latex-free Nitrile exam glove has been very favorable. The NFPA Standard does provide the user with additional test data and quality assurances not currently required to be conducted for 510K registration, the FDA pre-market notification required to sell gloves as Class 1 Medical Devices in the United States. These tests include the Biopenetration test, puncture test, dexterity test, and elongation test on isapropanol conditioned samples. Above and beyond the testing, the NFPA requirement for initial factory audit, quarterly follow up programs and annual recertification provide the end user with an on-going inspection process of both the products and factory, currently missing from the FDA 510K process. Currently, random inspections of gloves entering the US are performed by the FDA, mainly the watertight leak test. However, each 510K is normally sampled once per quarter, allowing for several untested containers of gloves to enter the United States on a daily basis. Basically, manufacturers of gloves are on the honor system, initial documentation submitted to the FDA for 510K approval as it pertains to product traceability, recall and quality are assumed to be adhered to. Because billions of pieces of gloves are manufactured for United States consumption every year, and because the process of making gloves has not achieved, by any standard, a defect free process, it is important that the NFPA has introduced a standard whereby factory audits are conducted to monitor compliance to quality procedures and glove design and formulation parameters.

This is a review of the stringent regulations for design and performance for emergency medical examination gloves particularly that of Nitrile exam gloves that are outlined by the NFPA.

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NFPA Standards SELECTION OF EXAMINATION GLOVES FOR EMERGENCY MEDICAL TECHNICIANS

LATEX ALLERGENS

NFPA Standards

SELECTION OF EXAMINATION GLOVES FOR
EMERGENCY MEDICAL TECHNICIANS