Testing Requirements for PPE Gloves

Gloves that are intended for use as personal protective equipment (PPE) must comply with different standards depending on the end use and market in which they are sold.

In the EU, protective gloves are regulated by range of standards. The standard applied depends on the intended use and the type of protection which is claimed for the product.

Medical gloves that are intended to protect a patient by minimizing transmission are classed as a Medical Device and should be tested using EN 455. The standard overs all types of materials, and both sterile and non-sterile products.

Medical gloves intended for surgical procedures are considered to be Medical Device Class IIa. This requires approval and certification by a Medical Device Notified Body and a sterile assessment. These products should be registered with the local health organization responsible for managing device.

Below is a summary of EN 455 by sections with test description or requirements.

Test methods

Test description

Description or requirements

EN 455-1

Freedom from holes

Water tightness test based on AQL 1.5 for examination gloves, 0.65 for surgical gloves

EN 455-2

Physical properties

Size requirements

Force at break (before and after challenge testing

Surgical gloves: ≥ 9N

Examination/Procedure gloves: ≥ 6N

Thermoplastic gloves: ≥ 3.6N

EN 455-3

Biological evaluation

Tests for evaluation:

  • EN ISO 10993-1 general principles on biological evaluation of medical devices
  • EN ISO 10993-5 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
  • EN ISO 10993-10 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization

Powdered level

For powder-free gloves: ≤ 2 mg/glove

Chemicals

Upon request– Disclose list of chemical ingredients either added during manufacturing or known to present in the product that are known to cause adverse health effects

Endotoxins

For gloves that are labelled with "low endotoxin content"

≤ 20 endotoxin units per pair of gloves

Proteins, leachable

Monitor the process limit of leachable protein in the finished gloves containing natural rubber latex by modified Lowry method

EN 455-4

Shelf life determination

Assessment criteria for determining shelf life so suitable "best before" date may be indicated.

EN ISO 374 specifies the requirements for protective gloves intended to protect the user against dangerous chemicals and micro-organisms.

Summary of EN ISO 374 by sections with test description or requirements.

Standard

Test description

Requirement

EN ISO 374-1

General requirement

Shall comply with EN ISO 21420 clause 4, clause 5, clause 7

Penetration

No leak for air leak test

No leak for water leak test

Degradation

Test as claimed in the marking and reported in the user instruction

Permeation

Type A: at least level 2 against a minimum of six test chemicals

Type B: at least level 2 against a minimum of three test chemicals

Type C: at least level 1 against a minimum of one test chemical

EN ISO 374-5

General requirement

Shall comply with EN ISO 21420 clause 4, clause 5, clause 7

Penetration

No leak for air leak test

No leak for water leak test

Protection against viruses

Shall exhibit no detectable transfer (<1 PFU/ml) of the Phi-X174 bacteriophage in the assay titer

In the U.S., there is a different approach and standards are based on the material type from which the glove is manufactured. The range of standards are:

  • ASTM D3577 Rubber Surgical Gloves
  • ASTM D3578 Rubber Examination Gloves
  • ASTM D5250 PVC Gloves
  • ASTM D6319 Nitrile Gloves
  • ASTM D6977 Polychloroprene Examination Gloves

The below table summarizes test specification covered by ASTM and EN standards.

Standard

Material

Freedom from holes

Dimensions

Physical properties

Powder free residue

Powder amount

Protein content

Antigenic protein content

Shelf life

ASTM D5250

Poly(vinyl chloride)

x

x

x

x

x

 

 

 

ASTM D3577

Rubber

x

x

x

x

x

x

x

 

ASTM D3578

Rubber

x

x

x

x

x

x

x

 

ASTM D6319

Nitrile

x

x

x

x

x

 

 

 

ASTM D6977

Polychloroprene

x

x

x

x

x

 

 

 

EN 455

All types

x

x

x

x

 

x

 

x

Sterility test is required to ensure product is compliance for sterile product. Gloves intended for medical purposes are medical devices and require a 510(k) submission for U.S. market.

 

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