Puncture resistance is measured as the force required to break through samples from gloves with a standard puncture needle. The design of this needle is comparable to that of a large nail.

To assess resistance from puncture by a needlestick, a 25 gauge hypodermic needle can be used.

Medical Devices Directive 93/42/EEC classifies devices according to the potential hazard, expected duration of contact and expected invasiveness. If a product conforms to the Medical Devices Directive it must carry a CE mark on its packaging, and may also provide a statement of its classification. In addition, the properties of medical devices are described by a range of standards.

Classification of Devices

• Class I - Non-invasive devices, for example examination gloves (entry into a bodily orifice is not considered invasive).
• Class I - Sterile - Sterilised class I devices, for example sterile procedure gloves.
• Class IIa - With respect to the portfolio of Polyco Healthcare products these are short term invasive devices, for example surgical gloves.

All Polyco Healthline Medical Gloves comply with the European Standard EN455 Medical Gloves for Single Use. The standard is divided into 4 parts covering:

• EN455-1 - Freedom from holes.
• EN455-2 - Physical properties.
• EN455-3 - Requirements for biological evaluation.
• EN455-4 - Requirements and testing for shelf life determination.

There are two stages that a glove manufacturer must go through to ensure that a product is suitable for food use:

1. Ensure that the product formulation is made from products listed in regulation 10/2011 (relating to plastic materials and articles intended to come into contact with foodstuffs). This is a positive list whereby the product concerned can only be made from the materials listed in this directive.
2. Perform migration testing to ensure that the article in contact with food does not leach anything into the food. This is detailed in the EN1186 series of standards (materials and articles in contact with foodstuffs - plastics).

If both of these criteria are met, the Food Contact symbol (see above) can be applied to the glove and/or packaging.

EN1186

This set of standards lays down what chemicals can be used to replicate the various food types as well as the methods used.

There are four food stuffs defined:

• Aqueous where plain water is used as the food simulant
• Alcoholic where 10% ethanol solution is used as the food simulant
• Acidic where 3% acetic acid solution is used as the food simulant
• Fatty where various equivalents are used as the food stimulant. Typically these are iso-octane, 95% ethanol or vegetable oil

Typically for gloves repeated extractions of 2 hours are carried out at 40°C to mimic repetitive transient contact.

EN1186 requires that there is a maximum overall migration limit from the article into the food of 10mg/dm², any article being used in contact with food must meet this requirement.

EN1186 also allows for reduction factors to be applied to fatty food. This is based on the fat content of the food and the ability of a particular foodstuff to extract component(s) out of an article in contact with food. Highly fatty foods such as oils have no reduction factors, while meats have a reduction factor of 4 and shelled roasted nuts have a reduction factor of 5.

This means that even when the overall migration limit of 10mg/dm² is exceeded, the article may still be suitable for use depending on the type of food being handled.

EN455 Medical Gloves for Single Use. Part 1 Requirements and Testing for Freedom From Holes

Gloves must pass this test in order to prove that they are an effective barrier against micro-organisms. A statistical sample taken from a batch of gloves is subject to checks for pinholes and leaks by filling with water. Gloves must achieve acceptance quality limit (AQL) of 1.5 or better in order to be used as examination, procedure or surgical gloves. AQL 1.5 is equivalent to a maximum risk of 1.5% that any given glove contains a pinhole capable of allowing water, and therefore micro-organisms, through the film.

EN455 Medical Gloves for Single Use. Part 2 Requirements and Testing for Physical Properties

This standard includes tests for glove dimensions, and physical strength. The requirements for physical properties depends on the glove classification (surgical/examination) and material (Latex, Nitrile, Vinyl, Polythene).

Our range of apparel is also regulated by the PPE Directive 89/686/EEC. Most of our workwear will fall under the minimal risk category. However, certain items are also regulated by specific industry standards.

Hazard Protective Coveralls, Category III

Our Shield® Plus, Shield® Advance and Shield® Ultimate coveralls.

EN ISO 13688: General Requirements for Protective Clothing

Defines general requirements for ergonomy, product design and comfort, sizing requirements according to wearer height, chest and waist circumference and specific labelling of the garment. We refer to numerical types of protection to define the level of protection of each coverall.

• Type 3: Liquid tight-jet Hazards (EN17491-3)
• Type 4: Liquid spray Hazards (EN17491-4)
• Type 5: Dry particles Hazards (EN13982)
• Type 6: Liquid splashes Hazards (EN13034)

In order to classify coveralls into types, other specific industry standards are required:

EN14126: Protection against Biological Hazards

Specifies the requirement of protective clothing against Infective Agents such as Bird Flu.

EN1073-2: Protection against Radioactive Hazards

Specifies the requirement of protective clothing against Radioactive contaminations.

EN1149: Test method for Anti-static properties

Specifies the requirements and test method for measurement of electrostatic charge decay.

Respirators (half masks)

The range of FFP masks is classified as Category III, complex design and are tested in accordance with the following harmonised standards:

EN149+A1: Protection against hazardous particles for Respiratory masks

Specifies the requirement of Respiratory Protective Face Masks. This standard is divided into 3 categories, which will define the level of filtering protection from each disposable face mask. The level of protection is calculated on the Nominal Protection Factor (NPF), the acceptable level of filtering efficiency based on the amount of hazardous substance in the air. The greater the number, the greater the protection.

FFP1 mask

• Protection from low toxicity levels
• 4 x NPF
• Filtration efficiency of 78%

FFP2 mask

• Protection from medium toxicity levels
• 12 x NPF
• Filtration efficiency of 92%

FFP3 mask

• Protection from high toxicity levels
• 50 X NPF
• Filtration efficiency of 98%

‘D’- Dolomite test. This test exposes the respirator to a concentration of dolomite dust at 400 ± 100 mg/m3 with dust size ranging from 0.7-12 µm. All respirators that have passed with additional optional test to EN149 will be marked with the symbol ‘D’ after the class of respirator. (eg: FFP3D)

Additional usage symbols include:

• NR - Non reusable in a single shift
• R - Reusable in a single shift 

Facemasks

Our medical facemasks DK01 are regulated by the Medical Devices Directive and are tested to and comply with the following European standard:

EN14683: Medical Face Masks Requirements and Test Methods

Defines the Bacterial Filtration Efficiency of the facemasks and divides its tests into four categories:

Part 1:

• Bacterial Filtration Efficiency in vitro (BFE)
• Standards of the filtration of a controlled concentration of Staphylococcus aureas.
• Results: BFE of =95% = Type I BFE of =98% = Type II

Part 2:

• Breathing Resistance (Delta P)
• Testing of the air flow pressure passing through the mask.
• Results: Type I & II (non splash resistant) = <29.4 KPa
• Type IIR (splash resistant) = <49.0 KPa

Part 3:

• Splash Resistance
• Testing of a determined quantity of artificial blood sprayed on the mask.
• Results: Type I & II not applicable
• Type IIR minimum 120 mmHg

Part 4:

• Microbial cleanliness
• The bioburden of the medical mask shall be <30 cfu/g

BSEN13592: Plastic refuse sacks for household waste collection.

BSENISO7965-2: Sacks drop test. Sacks made from thermoplastic flexible film.

Clinical waste sacks and bags: Regulated and supplied in compliance with the department of health HTM07-01 (Health Technical Memorandum - Safe Management of Healthcare Waste)

CHSA: HPC Healthline UK Ltd is a founder member of the CHSA (Cleaning and Hygiene Suppliers Association) which was founded to initiate tighter product quality controls supplied in the industry. The CHSA is a member of the British Cleaning Council setting standards for code of practice of businesses throughout the supply chain.

The Shield® range of wipes has been tested against a combination of standards detailed below dependent on the intended action of the wipe:

• EN1040: Chemical disinfectants and antiseptics: Basic bactericidal activity.
• EN1275: Chemical disinfectants and antiseptics: Basic fungicidal and yeasticidal activity.
• EN1276: Chemical disinfectants and antiseptics: Evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas.
• EN1650: Chemical disinfectants and antiseptics: Evaluation of fungicidal and yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas.
• EN13624: Chemical disinfectants and antiseptics: Evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area.
• EN13727: Chemical disinfectants and antiseptics: Evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area.
• EN14348: Chemical disinfectants and antiseptics: Evaluation of mycrobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants.
• EN13704: Chemical disinfectants and antiseptics: Evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and industrial use. 
• EN14476: Chemical disinfectants and antiseptics: Evaluation of Virucidal activity in the medical area.

Polyco Healthline offers a complete hygiene solution adapted to the HACCP (Hazard Analysis and Critical Control Points) requirement with its full range of disposable gloves and workwear.

HACCP is a systematic preventive approach to food safety and is used to minimise cross contamination during food processing. Food factories have the responsibility to control and establish high level of hygiene at all stages within the food manufacturing process. This principle enables manufacturers to put into place a large range of controlling measures and on-line checks during the manufacturing process and hygiene measures for production personnel.

In order to avoid any cross contamination between food preparation and handlers, all staff working in a food environment must respect a high level of hygiene and must wear clean and appropriate workwear.

Recommended workwear:

• Shoes or shoe covers specifically for the work area
• Headwear covering the hair completely
• Facemasks
• Disposable gloves

Recommendations for the correct usage of disposable gloves:

• Wash hands prior to donning the gloves and thoroughly dry before donning
• Cover all wounds or cuts
• Change gloves every 4 hours or when the film barrier is compromised.