Disposable gloves

Disposable gloves fall into two categories:

• Primary concern = protecting patient: Medical Device Regulation (EU) 2017/745. Applicable standard is EN455 for Single Use Medical Gloves.
• Primary concern = protecting wearer: Regulation (EU) 2016/425 on personal protective equipment.

Definition of "Medical gloves for single use " according to EN 455: gloves intended for use in the medical field to protect patient and user from cross-contamination, intended to be used on one individual during a single procedure.

For MSF:

• medical gloves = SMSU / SPPE family
• PPE gloves = PSAF family.

The two main types of disposable medical gloves are examination and surgical (including gynecological gloves) – each with a specific function.

Medical gloves are further designated by their material – nitrile, latex or other.

If the wearer is to be protected from chemical and physical risks as well as biological agents (e.g., during work in a microbiological laboratory or care of patients harboring highly pathogenic microorganisms), gloves declared as PPE must be used. Dual labeling of products for dual purposes as MD and PPE is possible.

Examination Gloves versus Surgical Gloves

General purpose examination gloves are most commonly used by caregivers and healthcare workers to protect themselves from contamination between caregiver and patient during an examination or procedure. These gloves are used during procedures that do not require sterile conditions when a risk of contact with biologic fluids exists (either from patient = most common or from caregiver = breach in hand skin), for example drawing blood for a blood test. Some of these gloves can also protect the wearer from harm caused by dangerous chemicals or pharmaceuticals

The primary purpose of surgical gloves is to act as a protective barrier to prevent possible transmission of micro-organisms between healthcare professionals and patients during surgical procedures.

Differences between surgical gloves and medical examination gloves (the type of gloves found in bulk containers in clinical examination rooms) are:

• Manufacturers of surgical gloves are required to meet a higher level of quality standards.
• Surgical gloves are sterile and individually packaged in pairs (or double pairs) with clear identification of right and left hand.
• They are anatomically shaped medical gloves with the thumb positioned towards the palmar surface of the index finger.
• Surgical gloves have a more precise range of sizing than medical examination gloves (sizes 5 ½ up to 9, per ½ size).
• Donning surgical gloves is according to a strict procedure.

Materials

Common surgical glove material: latex, neoprene, polyisoprene or nitrile. Material selected by MSF: standard surgical gloves are latex (latex allergies are rare in MSF projects for the moment), alternatives are gloves made of neoprene (polychloroprene) .

Common examination glove material: latex, vinyl or nitrile. Material selected by MSF: standard examination gloves are latex or nitrile.

LATEX gloves

The natural rubber latex is derived from physical and chemical processing of the sap of certain species of trees, mainly the Hevea braziliensis.

GMDN: glove made of Hevea natural rubber latex (NRL)

• Hevea-latex surgical glove, non-powdered (47178
• Hevea-latex examination/treatment glove, non-powdered, non-sterile (47172)

Properties

• Level of barrier protection: Excellent: long standing benchmark for barrier protection.
• Allergen content: Varies: latex contains protein and chemical allergens.
• Strength and durability: Excellent: very strong and durable, tensile strength typically 3000 psi or better. Is a heat sensitive item (storage)
• Elasticity: Excellent: superior to the other gloves. Memory is very high allowing the film always to return to its original shape. Elongation limit +/- 750%.
• Puncture resistance: Very good: very resistant to punctures but can be pierced by very sharp objects.
• Fit and comfort: Excellent due to its high elasticity and memory, preferred by surgeons.
• Chemical resistance: Good: provides good protection from most caustics and detergents. May be used for handling cytotoxic drugs.
• Economy: Very good
• Environmental impact: Excellent: easily decomposes in landfills (natural product), incineration produces mostly water and carbon dioxide

NITRILE gloves

The nitrile is a synthetic rubber latex, derived from Acrylonitrile Butadiene copolymer (NBR).

GMDN: glove made of nitrile

• Nitrile surgical glove, non-powdered (56291)
• Nitrile examination/treatment glove, non-powdered, non-sterile (56286)

Properties

• Level of barrier protection: Excellent: nitrile is highly resistant to punctures and tears.
• Allergen content: Very good: contains no latex proteins but contains some curing agents.
• Strength and durability: nitrile film is extremely strong with puncture resistance superior to all glove films. Tensile strength is well above 3000 psi.
• Elasticity: Very good: elongation typically 500% or better. Nitrile exhibits some memory effect allowing the film to adapt to the wearer’s hand.
• Puncture resistance: Excellent. Superior to all medical glove films currently available.
• Fit and comfort: Very good: due to the high elasticity and memory effect. Has a slightly tighter fit (choose a larger size)
• Chemical resistance: Excellent: resistance to most chemicals. May be used for handling cytotoxic drugs.
• Economy: price of nitrile is +/- similar to latex
• Environmental impact: Varies: does not decompose in landfills, incineration produces mostly water and carbon dioxide.

NEOPRENE gloves

GMDN: glove made of polychloroprene (neoprene)

• Polychloroprene surgical glove, non-powdered (57970)
• Polychloroprene examination/treatment glove, non-powdered (56288)

Properties

• Level of barrier protection: Very good, similar to latex
• Allergen content: Excellent: contains no latex proteins but a low level of chemical allergens
• Strength and durability: Very good: unbroken neoprene is very strong. Once punctured however the film tends to tear rapidly. Tensile strength typically 3000 psi or better.
• Elasticity: Excellent: close to that of latex, memory is very high allowing the film to retains its original shape. Elongation limit +/- 750%
• Puncture resistance: Good: neoprene is somewhat puncture resistant.
• Fit and comfort: Excellent: provides excellent comfort and fit due to its high elasticity and memory.
• Chemical resistance: Excellent: good resistance to most chemicals
• Economy: more expensive than latex
• Environmental impact: Varied: does not decompose in landfills. Incineration produces significant amounts of hydrochloric acid.

POLYISOPRENE gloves

GMDN: glove made of polyisoprene

• Polyisoprene surgical glove, non-powdered (56293)
• Polyisoprene examination/treatment glove, non-powdered (60624)

Properties

• Level of barrier protection: Fair: good barrier protection but more permeable than latex.
• Allergen content: Very good: contains no latex proteins but contains some curing agents.
• Strength and durability: Very good: polyisoprene is durable. Tensile strength typically 2500 psi or better.
• Elasticity: Excellent: similar to natural rubber.
• Puncture resistance: Good: is somewhat puncture resistant.
• Fit and comfort: Very good: similar to natural rubber but slightly stiffer
• Chemical resistance: fair protection against alcohol and other water based solutions.
• Economy: more expensive than latex
• Environmental impact: Varies: does not decompose in landfills, incineration produces mostly water and carbon dioxide.

VINYL gloves

Vinyl gloves are made ​​from polyvinyl chloride (PVC), plus a number of plasticizers to confer specific properties.

GMDN: Vinyl examination/treatment glove, non-powdered (47176)

Properties

• Level of barrier protection: Poor: breaks and punctures easily during use, fit around the wrist is baggy making it a poor barrier.
• Allergen content: Very good: contains no natural rubber proteins and no chemical curing agents.
• Strength and durability: vinyl is the weakest of the glove films. Tensile strength is typically below 2000 psi.
• Elasticity: Fair to poor: vinyl elasticity is limited and varies from brand to brand. Typical elongation limit is less than 500%. The film has limited memory.
• Puncture resistance: Poor: vinyl is punctured by sharp objects easily.
• Fit and comfort: Fair: low elasticity limits fit and comfort. The wrist diameter is usually very large making the glove baggy around the cuff.
• Chemical resistance: Fair, often less protection than the other polymer materials.
• Economy: Very good: similar to latex.
• Environmental impact: Poor: does not decompose in landfills, plasticisers may leach out. Incineration produces significant amount of hydrochloric acid.

Latex allergy and other skin reactions from surgical gloves

Healthcare workers and anyone with frequent exposure to latex are at the greatest risk for developing latex sensitivity and allergies. Symptoms range from minor skin irritation or redness to respiratory problems. Shock has been reported in rare cases.

• Irritant contact dermatitis – The gloves, chemicals used in glove manufacture, glove powder or sweat may have a direct irritant action on hands as a result of mechanical disruption of the skin due to the rubbing of gloves; it is not due to an allergic reaction.
• Allergic contact dermatitis – Often due to an allergy to rubber accelerators (chemicals used in the manufacturing of rubber). Can also be due to other glove chemicals such as preservatives, colorants, and other additives.
• Latex allergy – Due to allergy to natural rubber latex protein.

There is a big push by the healthcare industry to become latex-free to prevent further development of latex allergies. However, hand hygiene remains important: hands have to be washed thoroughly after glove removal.

Powdered versus unpowered Gloves

Powder is used to lubricate the gloves, making them easier to put on your hands. Cornstarch is most often used.

On December 19, 2016, the FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves. The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body's immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications.

Special inner coatings on gloves have now replaced powder in many gloves, thus eliminating powder-related complications.

MSF standard = non-powdered gloves.

European norms for single use medical gloves

• EN 455-1 : 2020: Medical gloves for single use - Part 1: Requirements and testing for freedom from holes. Routine testing is done by the watertightness test where the gloves are filled with 1 liter of water in a specific time. A minimum sample size equivalent to sample size code letter L ensures that an adequate assessment of the quality of the lot is obtained when the lot size is small or unknown. AQL (Acceptance Quality Limit = max % of the gloves presenting a defect) = 1.5 for examination gloves and 0.65 for surgical gloves. It is important that the minimum level of pinholes is kept, as the risk of getting an infection through the glove will be increased with a higher AQL level

• EN 455-2 : 2015: Medical gloves for single use - Part 2: Requirements and testing for physical properties.
• Dimensions: length and width (2 tables: one for surgical gloves, one for examination / procedure gloves)
• Strength: force at break in Newton (median values):
• ≥ 9.0 N for all surgical gloves
• ≥ 6.0 N for examination / procedure gloves not made from thermoplastics
• ≥ 3.6 N for examination / procedure gloves made from thermoplastic material: e.g. polyvinylchloride, polyethylene
• EN 455-3 : 2015: Medical gloves for single use - Part 3: Requirements and testing for biological evaluation, it specifies requirements for the evaluation of biological safety for medical gloves for single use.
• Chemicals: Gloves shall not be dressed with talcum powder (magnesium silicate). The manufacturer shall disclose, upon request, a list of chemical ingredients either added during manufacturing or already known to be present in the product.
• Medical gloves containing natural rubber latex shall be labelled on the packaging of at least the smallest packaging unit with symbol for latex. The labelling shall include the following or equivalent warning statement together with the symbol: “contains natural rubber latex which may cause allergic reactions, including anaphylactic responses”.
• The manufacturer shall monitor the endotoxin contamination of sterile gloves.
• For powder-free gloves the total quantity of powder shall not exceed 2 mg per glove, the labelling shall include a prominent indication of whether the glove is powdered or powder-free.
• The manufacturer shall strive to minimize the leachable protein level.
• EN 455-4 : 2009: Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
• Whenever there is any significant change to the product the manufacturer shall re-determine shelf life.
• Attention is drawn to the maintenance of the sterility for the given shelf life of the product.
• Manufacturers shall provide storage instructions to the end user.
• Test methods: real time shelf life determination and accelerated shelf life determination (gloves must keep all the performance after 7 days in a stove at 70°C)

ISO standards

• ISO 11193-1:2020: Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution (edition 3)
• ISO 10282:2014: Single-use sterile rubber surgical gloves - Specification

ASTM standards

• ​D3577: Standard Specification for Rubber Surgical Gloves: covers certain requirements for packaged sterile rubber surgical gloves of the natural rubber latex type (Type 1) and of the synthetic rubber latex type (Type 2).
• Thickness (single wall): fingers, palm & cuff: min. 0.1 mm
• Elongation at break: before aging = min 750%, after aging = min 560%
• Tensile strength: before aging = min 24 MPa, after aging = min 18 MPa

• D3578: Standard Specification for Rubber Examination Gloves

• D5151: Test Method for Detection of Holes in Medical Gloves

• D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension

• D6124: Test Method for Residual Powder on Medical Gloves

​Practical medical glove use in MSF

• Gloves must always be worn if there is a risk of contact with human body fluids or the patient’s mucous membranes or non-intact skin, especially during high risk procedures (blood cultures, blood sampling, placement and removal of venous lines, wound dressing, etc.).
• They must also be worn when handling laboratory sample tubes and soiled linens and equipment.
• They are always used when the care provider has a lesion on his or her hand (cut, injury, abrasion or skin condition).
• Wearing gloves is not recommended for contact with intact skin (for example, during physical therapy for rehabilitation, outpatient consultation, etc.).
• Single-use gloves are never washed; they are changed between patients and procedures (even on the same patient). They are donned just prior to contact, care procedure or treatment. They are removed as soon as the care procedure is over, and discarded in the medical waste bin.
• After removing gloves, hands should be washed (with soap and water) or disinfected (with an alcohol-based product).

Practical medical glove use (WHO)

• Gloves are effective in preventing contamination of health-care workers’ hands and helping reduce transmission of pathogens dependent upon two critical factors:
• They are used appropriately
• Timely hand hygiene is performed using the method of hand rubbing or hand washing.
• Safe glove use involves:
• Using the correct technique for donning gloves that prevents their contamination
• Using the correct technique for removing gloves that prevents health-care workers’ hands becoming contaminated
• The unnecessary and inappropriate use of gloves results in a waste of resource and may increase the risk of germ transmission.
• Health-care workers should be trained in how to plan and perform procedures according to a rational sequence of events and to use non-touch techniques as much as possible in order to minimize the need for glove use and change.
• If the integrity of a glove is compromised (e.g., punctured), it should be changed as soon as possible and complemented with hand hygiene.
• Double gloving in countries with a high prevalence of HBV, HCV and HIV for long surgical procedures (>30 minutes), for procedures with contact with large amounts of blood or body fluids, for some high-risk orthopaedic procedures, is considered an appropriate practice.
• Use of petroleum-based hand lotions or creams may adversely affect the integrity of latex gloves and some alcohol-based handrubs may interact with residual powder on health-care workers’ hands.
• The reuse of gloves after reprocessing or decontamination is not recommended.