EN 455 – European Standards for Medical Gloves

These European Standards cover the minimum properties that address certain essential requirements detailed in the Medical Device Directive 93/42/EEC.

EN 455-1

 Medical gloves for single use – Part 1

This standard specifies requirements and gives the test method for single use medical gloves in order to determine freedom from holes. The gloves should be sampled in accordance with ISO 2859-1 ”General Inspection level I“, but utilising a minimum sample size and corresponding acceptable/rejection number equivalent to sample size code letter ”L”. The compliance level for freedom from holes shall be an AQL of 1.5.

EN 455-2

Medical gloves for single use – Part 2

This standard specifies requirements and gives test methods for physical properties of single use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.

This standard does not specify the size of a lot. The recommended maximum individual lot size for production is 500.000. The sample size for each lot is 13 pieces, which the average of the 13 pieces samples must comply with the specification given in this standard for length, width and force at break see below tables 1 to 3:

Table 1: Dimensions of Surgical Gloves


Median length

Median width


≥ 250 mm

67 ± 4 mm


≥ 250 mm

72 ± 4 mm


≥ 250 mm

77 ± 5 mm


≥ 260 mm

83 ± 5 mm


≥ 270 mm

89 ± 5 mm


≥ 270 mm

95 ± 5 mm


≥ 270 mm

102 ± 6 mm


≥ 280 mm

108 ± 6 mm


≥ 280 mm

114 ± 6 mm


≥ 280 mm

121 ± 6 mm

Table 2: Dimensions of Examination & Procedure Gloves


Median length

Median width


≥ 240 mm

≤ 80 mm


≥ 240 mm

80 ± 10 mm


≥ 240 mm

95 ± 10 mm


≥ 240 mm

110 ± 10 mm


≥ 240 mm

≥ 110 mm

Table 3: Median values of force at break

Force at break
in Newton

Surgical gloves

Examination/procedure gloves




Throughout shelf life tested according to 5.2 and within 12 months of manufacture tested according to 5.3

≥ 9.0

≥ 6.0

≥ 3.6

a) Requirements for all surgical gloves.

b) Requirements for all examination gloves, except gloves made from themoplastic materials (e.g. polyvinylcloride, polyethylene).

c) Requriements for gloves made from themoplastic materials (e.g. polyvinylchloride, polyethylene).

EN 455-3

Medical gloves for single use – Part 3

This standard specifies requirements for the evaluation of biological safety for single use medical gloves. It gives requirements for labelling and disclosure of information relevant to the test methods used.

Medical gloves for single use shall be evaluated as described in the EN ISO 10993 series. A risk management process in accordance with EN ISO 14971 shall be established.

Gloves shall not be dressed with talcum powder (Magnesium silicate). Chemicals known to be allergic shall be avoided if technical alternatives exist. The manufacturer shall disclose, upon request, a list of chemical ingredients either added during manufacturing or already known to be present in the product such as accelerators, antioxidants and biocides, which are known to cause adverse health effects based on current data.

Endotoxin contamination of sterile gloves has to be controlled not exceed the limit of 20 endotoxin units per pair of gloves if the gloves are labelled: Low endotoxin level. Powder content not exceeds 2.0 mg per glove for powder free gloves and any glove containing more than 2.0 mg powder is a powdered glove. The manufacturer shall be monitoring the leachable protein in finished gloves containing natural rubber latex by the method specified in EN455-3.

In addition to the labelling specified in EN 1041 and the relevant symbols given in EN ISO 15223-1 and due to biological safety, medical gloves containing natural rubber latex shall labelled at least on the packaging.

EN 455-4

Medical gloves for single use – Part 4

This standard specifies requirements for shelf life for medical gloves for single use. It also specifies the requirements for labelling and the disclosure of information relevant to the test methods use. This applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time.

The medical gloves shall comply with the requirements of the EN 455 series of standards until the end of their stated shelf life provided they are stored according to the instructions supplied by the manufacturer. Manufacturers shall test the properties that are reasonably expected to alter over the shelf life of the product. These properties shall include, but are not limited to:

• force at break (according to EN455-2)

• freedom from holes (according to EN455-1)

• the gloves is fit for the intended purpose

• Pack integrity (sterile gloves)

This standard defines the methods to determine shelf life of medical gloves before any new product or products for which there has been a significant change to formulation or process can be marketed.

Since it is impracticable to complete real time ageing studies before introducing products to the market, accelerated stability studies based on kinetic principles can be used to assign a provisional shelf life. Such provisional shelf life assigned shall be verified by real time studies. Shelf life claims based on accelerated ageing shall not exceed three years. Shelf life determined through real time studies shall not exceed five years. Data supporting the shelf life claims made by the manufacturer shall be made available on request.