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Understanding the Norms & Standards for PPE in Hand Protection Safety.

Cut-Resistant Glove Standards For ANSI/ISEA 105 and EN:388.

Recognizing the need for more consistent testing methodolgy, as well as higher and more accurate ratings, the American National Standards Institue (ANSI) and International Safety Equipment Association (ISEA) have issued a new revision to the "American National Standard for Hand Protection" (ANSI/ISEA 105) and the European Union has proposed revisions to testing and raiting methods for "Protective Gloves Against Mechanical Risks" (EN 388).

Across The Cut-Resistant Scale, SHOWA Has You Covered.
ANSI/ISEA 105-16

What You Need To Know About The New ANSI/ISEA 105-16 Cut Resistant Glove Standards:

 

ANSI/ISEA 105-16 (ASTM F2992-15) 

 

• Measures in GRAMS of force up to 6000 gm (previously 3500 gm)

 

• Reporting is in 9 levels instead of the previous 5, to accommodate for stronger cut-protective fibres.

 

• Tests under the new standard have an “A” before the cut level

 

Dowload our Cut Resistant Glove Guide here for more information - www.cutgloves.showagroup.com 

CE CATEGORY
European Directive 89/686/EEC

CATEGORY I
Minor risks.

CATEGORY II
Reversible risks (injury), certified compliant by a notified body.

CATEGORY III
Irreversible risks (corrosion), certified compliant and tested by a notified body whose number is specified.

 
EN 420
General requirements and test methods
  • Technical information*
  • Glove markings
  • Sizes
  • Level of dexterity (1 to 5)
  • Innocuousness of the glove

 

* Printed on the packaging or on the user instruction of SHOWA gloves. For further details, contact your distributor or visit the website.

 
EN ISO 374: 2016

The standard defines requirement the capability of gloves to protect the user against penetration, permeation and degradation by chemicals and microorganisms. It classifies three types of gloves by level of protection (A, B, and C).

 
EN 374-2: 2014
Penetration resistance

The gloves must pass the air leak and/or water leak test, and meet the defined AQL inspection level. In an air leak test the interior of glove is pressurized with air and the surface is checked for holes. In a water leak test the glove is filled with water, and checked for the appearance of water droplets on the outside surface after a defined time period.
AQL (accepted quality level) is a measure of quality assurance based on random sampling procedure according to ISO 2859-1 used by manufacturers for measuring the likelihood of pinhole defects in a batch of gloves. An AQL of 1,5 accepts the statistical probability that there are less than 1,5% of the gloves with defects in the batch.

 

Performance levelAcceptable quality level unitInspection levels
Level 3< 0,65G1
Level 2< 1,5G1
Level 1< 4,0S4
EN 16523-1: 2015
(replaces EN 374-3) Resistance to chemical permeation - Until 21/04/2018

Test method to measure the resistance of  the PPE material to permeation by hazardous chemicals at molecular level and under continuous contact. The resulting value is the breakthrough time or the time needed by the hazardous liquid or gas to get in contact with the skin. The glove is classified in terms of breakthrough time performance level 1 to 6.

Measured  breakthrough timePermeation  performance index
> 101
> 302
> 603
> 1204
> 2405
> 4806


The standard defines a list of 18 chemicals. The minimum breakthrough time for a Type A glove is 30 mins (Level 2) for 6 chemicals, for a Type B it is 30 mins for at least 3 chemicals, and for Type C it is 10 mins (Level 1) for at least 1 chemical on the list.

Type of glovesBreakthrough time
A≥ 30 min for at least 6 chemicals
B≥ 30 min for at least 3 chemicals
C≥ 10 min for at least
1 chemical



The ‘chemical resistant’ glove pictogram must be accompanied by code letters for the tested chemicals for Type A and Type B gloves. Type C marked gloves are without any code letter.

List of chemicals:

Letter codeChemicalCAS numberClass
AMethanol67-56-1Primary alcohol
BAcetone6764-1Ketone
CAcetonitrile75-05-8Nitrile compound
DDichloromethane75-09-2Chlorinated hydrocarbon
ECarbon disulphide75-15-0Organic compound containing sulphur
FToluene108-88-3Aromatic hydrocarbon
GDiethylamine109-89-7Amine
HTetrahydrofurane109-99-9Heterocyclic ether
IEthyl acetate141-78-6Ester
Jn-Heptane142-85-2Saturated hydrocarbon
KCaustic soda 40%1310-73-2Inorganic base
LSulphuric acid 96%7664-93-9Inorganic mineral acid
M*Nitric acid 65%7697-37-2Inorganic mineral acid, oxidizing
N*Acetic acid 99%64-19-7Organic acid
O*Ammonium hydroxide 25%1336-21-6Organic base
P*Hydrogen peroxide 30%7722-84-1Peroxide
S*Hydrofluoric acid 40%7664-39-3Inorganic mineral acid, contact poison
T*Formaldehyde 37%50-00-0Aldehyde

 *New chemicals

 

 
EN 374-4: 2013
Resistance to chemical degradation

Degradation is the deleterious change in one or more properties of a protective glove material due to contact with a chemical. Indications of degradation can be delaminating, discoloration, hardening, softening, dimensional change, loss of tensile strength, etc. It is determined by measuring the percentage change in puncture resistance of the glove material after a continuous contact for 1 hour of the external surface with the challenge test chemical. The results of the degradation test must appear in the information leaflet for all three glove types.

EN 374-5: 2016
Protection against micro-organisms

Micro-organisms are defined by the standard as bacteria, fungi or viruses. To claim resistance to bacteria and fungi the glove must pass the penetration resistance test according to standard EN 374-2: 2014. If the glove passes ISO 16604: 2004 (method B) test it can claim resistance to viruses as well, and the term “VIRUS” will be added below the biohazard pictogram.

EN 388: 2016
Mechanical risks

Revision of EN 388: 2003
The EN 388 standard underwent revision in 2016. SHOWA gloves are in the process of being recertified by the notified bodies to conform to the revised standard. Currently reported ISO 13997 cut resistance values are indications until officially certified. In the meantime the existing certificates according to EN 388: 2003 remain valid.

 

a) ABRASION RESISTANCE (0-4)
Number of cycles required to abrade a hole using abrasive paper in a circular sample of glove material under constant pressure and motion.

b) BLADE CUT RESISTANCE BY COUP TEST (0-5)
Number of cycles required to cut a sample using a stainless steel circular blade under constant speed and low force of 5 newtons (approx. 510g). For materials that dull the blade, after a certain number of cycles without cut through, the ISO 13997 test is performed and becomes the reference cut resistance value.

c) TEAR RESISTANCE (0-4)
Force required to propagate a tear in a rectangular sample of a glove with a starting incision, to a maximum force of 75N (approx. 7,6kg).

d) PUNCTURE RESISTANCE (0-4)
Force required to puncture the sample with a standard size steel point at a constant speed of 10 cm/min.

e) BLADE CUT RESISTANCE BY ISO TEST (A-F)
Force in newtons (N) required to cut through a sample using a rectangular blade in a specified cut test machine such as Tomodynamometer (TDM). This test is optional unless the blade in Coup test becomes dull, whereupon it becomes the reference for cut resistance. A letter value is assigned as follows:

Level of protectionABCDEF
Force in newtons> 2≥ 5≥ 10≥ 15≥ 22≥ 30
Cut resistanceLOWMEDIUMHIGH

 

f) IMPACT RESISTANCE (P)
For protective gloves claiming impact resistance. Measures dissipation of force by the area of protection upon an impact of a domed anvil at an impact energy of 5 joules. Testing is carried out in accordance with the impact protection test for motorcycle protective gloves of EN 13594:2015 standard. A letter “P” is added on successful pass, while a fail remains unmarked.

Level X can also be applied for a – f above, which means “not tested”.

Level of protection12345
Abrasion resistance (number of cycles)> 100≥ 500≥ 2000≥ 8000-
Blade cut resistance by Coup test (index)> 1,2≥ 2,5≥ 5≥ 10≥ 20
Tear resistance (force in newtons)> 10≥ 25≥ 50≥ 75-
Puncture resistance (force in newtons)> 20≥ 60≥ 100≥ 150-

 

 

EN 511
Cold-related risks

Tested levels of glove performance in terms of the following risks:

  • Climatic or industrial cold transmitted by convection (0 to 4).
  • Climatic or industrial cold transmitted by contact (0 to 4).
  • Impermeability to water (0 or 1).

If the glove shows this symbol, it has achieved a performance index for (from left to right) climatic cold or industrial cold transmitted by convection, climatic cold  or industrial cold transmitted by contact, impermeability to water.
“0” means that during the test level 1 was not reached.
“X” means that the test was not performed or not possible.

EN 407
Heat-related risks

Tested levels of glove performance in terms of the following risks:

  • Resistance to flammability (0 to 4)
  • Resistance to contact heat (0 to 4)
  • Resistance to convective heat (0 to 3)
  • Resistance to radiant heat (0 to 4)
  • Resistance to small splashes of molten metal (0 or 1)
  • Resistance to large splashes of molten metal (0 or 1)

 

“0” means that during the test level 1 was not reached.
“X” means that the test was not performed or not possible.

 
EN 1149-1
Antistatic properties

Tested level of glove surface resistivity. Measured in ohms/square (Ω), this indicates the capacity of the glove to disperse via a dissipative and/or conductive effect  the accumulated static electricity discharges on the operator’s hand.

RISKS RELATED TO FOOD CONTACT

It is applied to materials and articles that, at finished state, are intended to come into contact or are brought into contact with foodstuffs or with water that is for human consumption. According to Regulation 1935/2004: «The materials and articles must be manufactured in accordance with good manufacturing practice so that, under normal or foreseeable conditions for their use, they do not transfer their constituents to food in quantities which could:

  • Present a danger to human health,
  • Results in an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof.»

All SHOWA gloves with the «food contact» logo are conform to Regulation (EU) No 1935/2004 and the Regulation (EU) No 2023/2006.

 
EUROPEAN DIRECTIVE 93/42/EEC
Covering medical examination and surgical gloves
 
EN 455-1
Freedom from holes

A random sample of gloves is tested for freedom of holes by undergoing a water leak penetration test. The gloves are filled with 1l of water and must remain completely leak proof over a defined period of time. A failed test results in a higher AQL value, which for medical gloves sold in Europe must be 1,5 or lower.


AQL (accepted quality level) is a quality sampling procedure ISO 2859-1 used by manufacturers for measuring the % likelihood of pinhole defects in a batch of single use gloves. An AQL of 1,5 brings a statistical probability that less than 1,5% of the gloves in the batch will have defects.

 
EN 455-2
Physical properties

Size and tensile strength requirements for single use medical gloves. 
No less than 240mm in median length and 95mm (±10mm) median width to provide adequate protection along full length of the hand (exception for long cuff gloves).


Strength is measured by elongation until breaking point, indicated as Force 
At Break (FAB) in newtons (N). FAB is measured on standard sample and on a rapid aged sample that is kept at 70°C for 7 days to simulate glove deterioration during prolonged shelf life. FAB requirements differ per glove material and if the glove is for examination or surgical purpose. Indication of median minimum FAB values:

Force at break (N) during shelf life

 Rubbers
(e.g. natural latex, nitrile)
Thermoplastics
(e.g. PVC, vinyl, butyl)
Examination glove≥ 6,0≥ 3,6
Surgical glove≥ 9,0-
 
EN 455-3
Biological evaluation

A number of important requirements are specified to maintain biological safety of the glove for the medical practitioner as well as the patient. “LATEX” pictogram on packaging for natural latex rubber gloves is mandatory. No terms suggesting relative safety of usage are permitted i.e. low allergenicity, hypoallergenicity or low protein content. Powder residue, which is seen as unwanted contaminant on medical gloves, must not exceed 2mg per glove with “powder-free” claim. Water extractable latex protein content in latex gloves must not exceed 50 microgram per gram of rubber to minimize latex exposure that can cause allergic reactions. The level of endotoxins generated by bacteria on sterile gloves that claim “low endotoxin level” may not exceed 20 EU per glove pair (EU=Endotoxin Units).

 
EN 455-4
Shelf life determination

The standard ensures there is no performance degradation during storage period prior to use. Accelerated aging tests are performed on glove samples to determine shelf life, to enable manufacturers to prove that their product will withstand (usually) up to 3 years and in some cases up to 5 years without losing their strength and protection properties.

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