What are the Certification Requirements for Medical Gloves?

Certification Requirements for Medical Gloves?

What are the Certification Requirements for Medical Gloves?

Why are certifications important for medical gloves?

 

Medical gloves, including examination gloves, surgical gloves, and chemotherapy gloves (medical gloves for handling chemotherapy agents), are the first line of defense for health care workers and patients.  It has been confirmed in several clinical studies that gloves are effective in preventing contamination of health care workers’ hands and helping reduce transmission of pathogens when being used appropriately. The World Health Organization (WHO) recommends that gloves should be used during all patient-care activities that may involve exposure to blood and all other bodily fluids during contact precautions and outbreak situations.

 

Nevertheless, disposable medical gloves are not all the same even though they look very similar to each other. Substandard medical gloves may be easily permeated or pierced, or even cause allergic reactions. More importantly, pathogens may gain access to the users’ hands via small defects in gloves, thus increasing the risk of infection. Since it is difficult to identify whether a box of medical gloves is genuinely qualified without professional equipment, the best strategy is to get familiarized with different medical glove certifications which make clear and detailed regulations about the quality, thickness, color, packaging, and information printed on the box, etc.

 

What is the FDA’s policy on medical gloves during COVID-19?

 

The U.S. Food and Drug Administration (FDA) issued a guidance document in March 2020 to provide a policy to help expand the availability of surgical apparel for health care professionals, including gowns (togas), hoods, and surgeons and patient examination gloves during the COVID-19 pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 as declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary. In general, the FDA’s guidance documents do not constitute legally enforceable responsibilities, but merely describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

 

According to the guidance document, the FDA makes specific recommendations for patient examination gloves and surgeon’s gloves. In general, the FDA recommends that health care providers follow current guidance issued by the Centers for Disease Control and Prevention (CDC) regarding personal protective equipment (PPE) that should be used during the COVID-19 outbreak. Health care employers must also comply with the standards of the Occupational Safety and Health Administration (OSHA) that require PPE to protect workers and that apply to infectious disease hazards. 

 

In order to address the shortage of patient examination gloves and surgeon’s gloves during the pandemic, the FDA does not intend to object to the distribution and use of these two types of gloves that do not comply with their respective regulatory requirements so long as the gloves do not create an undue risk in light of the public health emergency.

 

Table 1. FDA regulatory requirements for patient examination gloves and surgeon’s gloves 

Patient Examination Gloves Surgeon’s Gloves
Prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81 Prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81
Registration and Listing requirements in 21 CFR 807 Registration and Listing requirements in 21 CFR 807
Quality System Regulation requirements in 21 CFR 820 Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20
Reports of corrections and removals in 21 CFR Part 806  
Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20  

 

Table 2. The FDA currently believes when the following requirements are met, no undue risk would be created for patient examination gloves and surgeon’s gloves:

Patient Examination Gloves Surgeon’s Gloves
The product includes labeling that accurately describes the product as an “unpowdered glove” (as opposed to a surgeon’s or patient examination glove), accurately describes its sterility status when individually packaged (non-sterile), does not claim the product as being free of a specific material (e.g., latex-free), and includes a list of the body contacting materials. The product meets the standard specification consistent with the consensus standard ASTM D3577: Standard Specification for Rubber Surgical Gloves.
The product includes labeling with general statements and makes recommendations that would reduce sufficiently the risk of use, for example, a general statement about devices that have not been cleared by FDA and recommendations against use: when FDA-cleared gloves are available, in surgical settings or where significant exposure to liquid bodily or other hazardous fluids may be expected, and in clinical settings where the infection risk level is high. The product includes labeling that accurately describes the product as being unpowdered, accurately describes its sterility status (sterile) and the sterilization method used, does not claim the product as being free of a specific material (e.g., latex-free), and includes a list of the body contacting materials.
The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses with chemotherapy drugs, fentanyl, and other opioids, uses for allergy or dermatitis prevention, uses for antimicrobial or antiviral protection, or uses for infection prevention or reduction. The product includes labeling with general statements and makes recommendations that would reduce sufficiently the risk of use, for example, a general statement about devices that have not been cleared by the FDA and recommendations against use when FDA-cleared surgeon’s gloves are available.
  The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses with chemotherapy drugs, fentanyl, and other opioids, uses for allergy or dermatitis prevention, uses for antimicrobial or antiviral protection, or uses for infection prevention or reduction.

 

Lastly, the FDA recognizes that when alternatives such as FDA-cleared gowns, other surgical apparel and/or gloves are unavailable, individuals, including healthcare professionals, might improvise PPE. The FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared gowns, other surgical apparel, and/or gloves, are available.

 

What types of gloves does the FDA’s policy apply to?

 

Gloves are devices when they meet the definition of a device set forth in section 201(h) of the FD&C Act. Under section 201(h) of the FD&C Act, these products are devices when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease. Such devices are required to follow the FDA’s marketing authorization and other requirements in the FD&C Act. When evaluating whether glove products are intended for a medical purpose, the FDA will consider, among other considerations, whether:

  1. they are labeled or otherwise intended for use by a health care professional;
  2. they are labeled or otherwise for use in a health care facility or environment; and
  3. they include any drugs, biologics, or anti-microbial/anti-viral agents.

 

Specifically, the FDA’s policy applies to the following types of gloves:

Glove Type Product Code
Patient Examination Glove FMC
Latex Patient Examination Glove LYY
Polymer Patient Examination Glove LZA
Finger Cot LZB
Vinyl Patient Examination Glove LYZ
Powder-Free Guayle Rubber Examination Glove OIG
Powder-Free Polychloroprene Patient Examination Glove OPC
Radiation Attenuating Medical Glove OPH
Specialty Patient Examination Glove LZC
Surgeon’s Gloves KGO
Powder-Free Non-Natural Rubber Latex Surgeon’s Gloves OPA

 

The FDA’s policy does not apply to powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. These products are banned devices under 21 CFR 895.102 and 895.103 and are not eligible to be distributed in the United States.

 

Which medical gloves are FDA-cleared?

 

Medical gloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device that is not subject to premarket approval. The FDA reviews these devices to ensure that performance criteria such as leak resistance, tear-resistance, and biocompatibility are met. To identify FDA-cleared medical gloves, search the 510(k) Premarket Notification database using the product codes for medical gloves listed in the table above.

 

CE Certification for gloves

 

CE certification or CE marking is a conformity marking consisting of the letters “CE”, which is an abbreviation for “conformité européenne” (French for European conformity). By affixing the CE marking, a manufacturer declares that its products meet all the European Union (EU) legal requirements regarding health, safety and environmental protection. CE marking is mandatory for products within certain categories, such as medical devices and personal protective equipment.

 

It is the manufacturer’s responsibility to verify that its products comply with relevant requirements before selling them in the market. In some cases, it is required to have the product examined by a designated third-party conformity assessment body.

 

The CE marking legislation has harmonized the product requirements throughout Europe. Once a manufacturer obtains the right to affix the CE marking, its products can access and circulate freely in all EU countries without additional requirements or certification.

 

EN Standards

 

EN is an abbreviation for “Europäische Norm” (German for “European Norm”), i.e. European Standards, which are a series of different technical standards for products, production processes, services or test-methods ratified by one of the three European standards organizations (European Committee for Standardization (CEN), European Committee for Electrotechnical Standardization (CENELEC), or European Telecommunications Standards Institute (ETSI)).

 

Below are some EN standards for gloves:

 

EN 420:2003 Protective gloves – General requirements and test methods

Scope

This standard defines the general requirements and relevant test procedures for glove design and construction, resistance of glove materials to water penetration, innocuousness, comfort and efficiency, marking and information supplied by the manufacturer applicable to all protective gloves.

What types of gloves are required?

Protective gloves, it can also be applicable to arm protectors and gloves permanently incorporated in containment enclosures.

*This standard was withdrawn on 11 November 2009 and later superseded by EN ISO 21420:2020.

 

EN 374-1:2003 Protective gloves against chemicals and micro-organisms – Part 1: Terminology and performance requirements

Scope

This standard specifies the requirements for gloves to protect the user against chemicals and/or micro-organisms and defines terms to be used. This standard should be used in conjunction with EN 420 and does not specify requirements for protection against any mechanical hazards. 

What types of gloves are required?

Gloves that aim to protect the user against chemical splash hazards. A chemical splash may still permeate through the glove and cause harm to the user, thus it is better to only use gloves for which the manufacturer can provide chemical permeation data.

*This standard was withdrawn on 23 November 2016 and superseded by EN ISO 374-1:2016.

 

EN 374-2:2003 Protective gloves against chemicals and micro-organisms – Part 2: Determination of resistance to penetration 

Scope

This standard specifies a test method for the penetration resistance of gloves that protect against chemicals and/or micro-organisms. At this time, it is believed that gloves that resist penetration, when tested according to EN 374, will form an effective barrier to micro-biological hazards.

What types of gloves are required?

Protective gloves against chemicals and microorganisms.

*This standard was withdrawn on 17 December 2014 and later superseded by EN ISO 374-2:2019.

 

EN 374-3:2003 Protective gloves against chemicals and micro-organisms – Part 3: Determination of resistance to permeation by chemicals

Scope

This standard specifies the determination of the resistance of protective glove materials to permeation by potentially hazardous non-gaseous chemicals under the condition of continuous contact. It is emphasized that the test does not represent conditions likely to be found in service, and the use of test data should be restricted to comparing materials chiefly on a relative basis in broad categories of breakthrough times.

What types of gloves are required?

Protective gloves against harsh chemicals (immersion protection).

*This standard was withdrawn on 18 February 2015 and later superseded by EN 16523-1:2015.

 

EN 421:2010 Protective gloves against ionizing radiation and radioactive contamination

Scope

This standard specifies requirements and test methods for gloves to protect against ionizing radiation and radioactive contamination. The standard is applicable to gloves offering protection to the hand and various parts of the arm and shoulder. It applies also to gloves to be mounted in permanent containment enclosures. This European Standard also applies to intermediary sleeves used between a glove and a permanent containment enclosure. The requirements of this European Standard do not apply to protective gloves against X-ray radiation.

What types of gloves are required?

Protective gloves against radioactive particle contamination.

 

EN 1149-5 Protective clothing – Electrostatic properties – Part 5: Material performance and design requirements

Scope

This standard specifies material and design requirements for electrostatic dissipative protective clothing, including hoods and caps, used as part of a total earthed system, to avoid incendiary discharges, where the minimum ignition energy of an explosive atmosphere is not less than 0,016 mJ. The material and design requirements do not presume adequate earthing of additional equipment worn or carried in contact with clothing, e.g. breathing apparatus, etc. If such additional equipment is required to be earthed, other requirements beyond the scope of this European Standard may be necessary. The scope of this standard does not include electrostatic dissipative protective gloves or footwear that are separate and not integral parts of garments. This Standard is not applicable for protection against mains voltages.

What types of gloves are required?

Antistatic claims can be made on PPE Category III disposable gloves if they have been tested against either EN1149-1:2006 or EN1149-3:2004 and satisfy at least one of the required levels: (1) surface resistance (EN 1149-1:2006) must be less than 5 x 1010 ohms; (2) induction charging/static decay (EN 1149-3:2004) half decay time < 4 s or shielding factor > 0.2.

 

EN 388:2003 Protective gloves against mechanical risks

Scope

This standard specifies requirements, test methods, marking and information to be supplied, for protective gloves against the mechanical risks of abrasion, blade cut, tear and puncture. This standard is only applicable in conjunction with EN 420. The test methods developed in this standard can also be applicable to arm protectors which are protective devices separate from the glove or the clothing.

What types of gloves are required?

Protective gloves against mechanical risks.

*This standard was withdrawn on 2 November 2016 and later superseded by EN 388:2016.

 

EN 407:2004 Protective gloves against thermal risks (heat and/or fire)

Scope

This standard specifies test methods, general requirements, levels of thermal performance and the marking for protective gloves against heat and/or fire. It should be used for all gloves which protect the hands against heat and/or flames in one or more of the following forms: fire, contact heat, convective heat, radiant heat, small splashes or large quantities of molten metal. There are other standards relevant to specific applications, for example, firefighting or welding. Product tests may only give performance levels and not protection levels.

What types of gloves are required?

Protective gloves against thermal risks (heat and/or fire).

 

*This standard was withdrawn on 8 April 2020 and superseded by EN 407:2020.

 

EN 511:2006 Protective gloves against cold

Scope

This standard specifies the requirements and test methods for gloves that protect against convective and conductive cold down to -50°C. This cold can be linked to climatic conditions or industrial activity. The specific values of the different performance levels are decided by the special requirements for each class of risk or the special areas of application. Product tests may only give performance levels and not levels of protection.

What types of gloves are required?

Protective gloves against cold.

 

EN 455 Medical gloves for single-use

Scope

This standard sets out the requirements and testing methods for any gloves intended for medical purposes. There are four parts to it: 

  • EN 455-1: Requirements and testing for freedom from holes
  • EN 455-2: Requirements and testing for physical properties
  • EN 455-3: Requirements and testing for biological evaluation
  • EN 455-4: Requirements and testing for shelf-life determination

These industry standards are created to ensure gloves used during medical examination and treatment can prevent contamination of health care workers’ hands and reduce the transmission of pathogens or other harmful substances.

What types of gloves are required?

Any gloves that could be used for medical tasks.

 

Micro-organism risk & medical gloves

 

In general, the smaller the micro-organism, the greater the risk of penetration through a defect in gloves. In order to assess the risk of micro-organism penetration in protective gloves, the EN 374-2 standard is usually adopted.

 

EN 374-2:2003 specifies a test method for the penetration resistance of gloves that protect against chemicals and/or micro-organisms. At the time when the standard is published, it is believed that gloves that resist penetration, when tested according to EN 374, will form an effective barrier to micro-biological hazards.

 

In addition to EN 374-2 test standard, ISO 16604:2004 and ASTM F1671-97b (Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-borne Pathogens using Phi-X174 Bacteriophage Penetration as a Test System) are globally recognized test standards for the assessment of glove resistance specifically to penetration by viruses. 

 

Which types of gloves are best suited for your purchase? 

 

The gloves you choose will depend on the nature of the task to be performed (whether there will be hazardous substances and the chemical characteristics of such substances matter). It will also depend on the nature of the contact with the hazardous substance (whether the contact is prolonged, intermittent, or fully or partially immersed). In addition, it is important to select gloves with the appropriate level of CE certification.

 

Other considerations for choosing the right gloves include: 

  1. risks of allergy:
    1. synthetic materials such as nitrile may trigger fewer allergic reaction than latex
    2. chemical accelerators such as thiazoles, thiurams, and dithiocarbamates are known chemical agents which can potentially trigger allergy; therefore accelerator-free products may be a better choice
  2. ensure to purchase the correct size of gloves which will fit
  3. performance features such as grip, length, dexterity, comfort, and insulation

 

Conclusion

 

Since the beginning of the COVID-19 pandemic, there have been numerous reports about falsified or substandard medical products, including medical gloves. As medical gloves are the first line of defense between health care workers’ hands and the patients’ body fluids (such as blood, respiratory secretions, vomit, urine, or feces), certain hazardous drugs or some potentially contaminated items, the quality of medical gloves cannot be emphasized enough. In this regard, only high-quality medical gloves can effectively prevent contamination of health care workers’ hands and reduce the transmission of pathogens.

 

In order to obtain qualified products, it is important to have a general understanding of the certification requirements for medical gloves, including the FDA requirements, CE marking, and EN industrial standards discussed above.

 

If you are interested in high quality medical products, please visit our product page for more details or contact us here for more information.

 

Reference: 

  1. Understanding glove certification. (n.d.). Https://Www.Kcprofessional.Co.Uk/. https://www.kcprofessional.co.uk/media/54391844/Glove%20Certification%20guide%20-%20from%20KIMTECH.pdf
  2. Center for Devices and Radiological Health. (n.d.). Medical Gloves for COVID-19. U.S. Food and Drug Administration. Retrieved September 28, 2021, from https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-gloves-covid-19
  3. CE marking – obtaining the certificate, EU requirements. (n.d.). Your Europe. Retrieved September 28, 2021, from https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm
  4. Glove Use Information Leaflet. (n.d.). WHO. https://www.who.int/gpsc/5may/Glove_Use_Information_Leaflet.pdf
  5. iTeh Standards – The source for standards and specifications. (n.d.). ITeh Standards Store. Retrieved September 28, 2021, from https://standards.iteh.ai/
  6. Center for Devices and Radiological Health. (2020, March 30). Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health

 

 

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Disclaimer: 

The information contained in this article is for general information purposes only. The Company does not guarantee the accuracy, relevance timeliness or completeness of any information, and the Company assumes no responsibility for errors or omission in the content of this article. 

 

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