Complex Design covers the highest level of risk, otherwise defined as irreversible and mortal risk. Disposable gloves in this
category are typically those gloves that provide protection against chemical and microorganisms. For these gloves the following
normative references may apply: ISO 21420:2020+A1:2022 (general requirements for gloves), ISO 374-1:2016+A1:2018 (terminology and
performance requirements for chemical risks) and ISO 374-5:2016 (terminology and performance requirements for
micro-organisms risks).
Crucially complex design brings the need for regular auditing by an external organization body, called a Notified Body. The
presence of the Notified Body is clearly evident, as under the CE mark will appear four digits (e.g. 0598 = SGS, 0493=Centexbel,
0123=TÜV etc). The Notified Body validates the quality assurance system used by the manufacturer.
In addition, disposable gloves that have been registered as Complex Design will typically display two or three pictograms identifying
the relevant standards to which they have been tested.
REFERENCE | SCOPE |
ISO 374-1:2016+A1:2018 | Protective gloves against dangerous chemicals and micro-organisms – Part 1: Terminology and performance requirements for chemical risks. |
EN 16523-1:2015+A1:2018 | Determination of material resistance to permeation by chemicals – Part 1: Permeation by liquid chemical under conditions of continuous contact. |
ISO 374-2:2019 | Protective gloves against dangerous chemicals and micro-organisms – Part 2: Determination of resistance to penetration. |
ISO 374-4:2019 | Protective gloves against dangerous chemicals and micro-organisms – Part 4: Determination of resistance to degradation by chemicals. |
Gloves are classified as Type A, B or C depending on their performance level when tested against a number of chemicals and degradation
expressed in terms of mean average (% change in puncture resistance before and after chemical exposure).
CODE | CHEMICAL | CODE | CHEMICAL |
A | Methanol | J | n-Heptane |
B | Acetone | K | Sodium Hydroxide 40% |
C | Acetonitrile | L | Sulphuric Acid 96% |
D | Dichloromethane | M | Nitric acid 65% |
E | Carbon disulphide | N | Acetic acid 99% |
F | Toluene | O | Ammonium hydroxide 25% |
G | Diethylamine | P | Hydrogen peroxide 30% |
H | Tetrahydrofuran | S | Hydrofluoric acid 40µ |
I | Ethyl acetate | T | Formaldehyde 37% |
REFERENCE | SCOPE |
ISO 374-5:2016 | Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks. |
ISO 374-2:2019 | Protective gloves against dangerous chemicals and micro-organisms – Part 2: Determination of resistance to penetration. |
ISO 16604:2004 Procedure B | Clothing for protection against contact with blood and body fluids – Determination of resistance of protective clothing materials to penetration by blood-borne pathogens – Test method using Phi-X174 bacteriophage. |
ISO 374-2 :2019 remains the basic test for assessing resistance to penetration by micro-organisms. Here performance is measured
on the basis of AQL (AQL<4 or Level 1 to AQL <0.65 or Level 3, with Level 3 being the highest performance level). For protective
gloves against bacteria and fungi, the biohazard pictogram is applied.
For protection against bacteria, fungi, and virus, the biohazard pictogram is accompanied with the term “VIRUS “underneath.
To fulfil this requirement, the glove must be tested according to ISO 374-2:2019 for bacteria and fungi and also tested according
to ISO 16604: 2004 (Method B) using the bacteriophage penetration test.
MICRO-ORGANISMS RESISTANT | VIRUS RESISTANT |
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Level 1 | AQL<4 |
Level 2 | AQL<1.5 |
Level 3 | AQL<0.65 |
REFERENCE | SCOPE |
EN 421:2010 |
Protective gloves against ionizing radiation and radioactive contamination. |
REFERENCE | SCOPE |
EN 455-1:2020 | Medical gloves for single use – Part1: Requirement and testing for freedom from holes. |
EN 455-2:2015 | Medical gloves for single use – Part 2: Requirement and testing for physical properties. |
EN 455-3:2015 | Medical gloves for single use – Part 3: Requirement and testing for biological evaluation. |
EN 455-4:2009 | Medical gloves for single use – Part 4: Requirement and testing for shelf-life determination. |
REFERENCE | SCOPE |
ANSI/AAMI/EN ISO 1137-2:2015 | Gamma Sterilization Dose Auditing |
ASTM D257-07 | Standard Test Methods for DC Resistance or Conductance of Insulating Materials |
ASTM D257-36 | Standard Test Methods for DC Resistance or Conductance of Insulating Materials |
ASTM D3578-05 | Standard Specification for Rubber Examination Gloves |
ASTM D3767-03 (2020) | Standard Practice for Rubber—Measurement of Dimensions |
ASTM D412-06ae2 | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
ASTM D412-06ae2 | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
ASTM D5712-15 (2020) | Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method |
ASTM D6124-06 | Standard Test Method for Residual Powder on Medical Gloves |
ASTM D6319-10 | Standard Specification for Nitrile Examination Gloves for Medical Application |
ASTM D6978-05 (2019) | Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs |
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 |
ASTM F720-81 | Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
ASTM D573-04 (2019) | Standard Test Method for Rubber—Deterioration in an Air Oven |
Directive 72/2002/EC | relating to plastic materials and articles intended to come into contact with foodstuffs |
EC 1935/2004 | Directive on materials and articles intended to come into contact with food |
EN 1149-1/2/3 & 5 | Protective clothing – Electrostatic properties |
FDA 21CFR177.2600 | FDA – Food for Human Consumption – Indirect Food Additives: Polymers – Rubber article intended for repeated use |
IEST-RP-C005.4 (2013) | Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments |
ISO 13485:2016 | Medical devices – Quality management systems — Requirements for regulatory purposes |
ISO 21171:2006 | Medical gloves – Determination of removable surface powder |
ISO 9001:2015 | Quality management systems — Requirements |
ISO 14001:2015 | Environmental management systems |
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