Quality gloves

High quality is what we offer.

The products that we source are controlled under EU and national Regulations and Compliance. The CobaMed Regulatory Compliance and QC team has an important role in the selection of products and suppliers during the sourcing and selection phase.
Certified quality

Legislative Information

The prerequisite for placing disposable gloves on the market in the European Economic Area is confirmation of compliance with all the applicable EU requirements by means of CE marking. Protective gloves, as part of personal protective equipment, protect the user’s hands and, if necessary, the forearms of the user from external influences (=self-protection).
t patients and health care professionals from contamination. The double declaration of a disposable glove, both as a medical device and a and as a product of personal protective equipment, is possible. The guidelines form the basis for the classification of the various products into categories or classes.

Examination gloves/medical gloves

Regulation: Medical Devices Regulation (EU) No. 2017/745 in Germany currently implemented by the Medical Devices Act and associated ordinances. Risk classes
  • Class I: Non-sterile examination gloves. They must meet the requirements for CE marking, the conformity of which is confirmed by the manufacturer.
  • Class IIa: Surgical operating gloves. They must be tested and certified by an independent accredited institute. certified. Here, too, the CE marking with four digits serves to identify the institute.

Standards

  • EN 455 This European standard serves as a guideline for testing single-use medical gloves for quality, physical properties, glove dimensions, tear resistance, resistance to biological hazards and durability. hazards and durability.
  • EN 455-1 Requirements and testing for leak tightness.
  • EN 455-2 Requirements and testing for physical properties.
  • EN 455-3 Requirements and testing for biological evaluation.
  • EN 455-4 Requirements and test for determination of minimum durability.

Protective gloves/personal protective equipment

Regulation: PPE Regulation (EU) 2016/425 Risk categories
  • Category I: Protection against minor risks.
  • Category II: Protection against medium risks.
  • Category III: Protection against lethal risks and irreversible damage to health.

Standards

  • EN 420 General requirements and test methods.
  • EN ISO 374-1 Protective gloves against hazardous chemicals and micro-organisms, terminology and performance requirements for chemical risks.
  • EN ISO 374-2 Protective gloves against hazardous chemicals and microorganisms, determination of resistance to penetration.
  • EN 16523-1 (replaces EN ISO 374-3) Protective gloves against chemicals and microorganisms, determination of resistance to permeation.
  • EN 374-4 Protective gloves against chemicals and microorganisms, determination of resistance to degradation by chemicals.
  • EN ISO 374-5 Protective gloves against hazardous chemicals and microorganisms, terminology and performance requirements for risks due to microorganisms.

Protective gloves against hazardous chemicals and microorganisms according to EN ISO 374-1 and 374-2

Degradation test according to EN 374-4 Impairment of the physical properties of the glove due to contact with a chemical substance

Notice:

To declare chemical protection against one listed substances, both the breakthrough time and the the breakthrough time as well as the degradation must be determined. must be determined. The test result of the degradation test must be instructions for use be stated.

Protection against microorganisms according to EN ISO 374-5.

For protection against bacteria and fungi, the glove must pass the penetration test according to standard EN 374-2. If protection against viruses is also required, an additional bacteriophage penetration test must be carried out and passed in accordance with ISO 16604:2004 (method B) must be carried out and passed.

Gloves for protection from bacteria and fungi.

Gloves for protection from bacteria, fungi and viruses.

Special regulations for the handling of food products

The framework regulation VO (EU) No. 1935/2004 specifies the requirements for materials that come into contact with food. Vinyl gloves are additionally subject to Regulation (EU) No. 10/2011.

Certified quality

Symbols overview

Various symbols provide you with important information about the product at first glance. This may include information on glove specifications, supply chain and storage conditions, legal requirements and classifications, warnings, protection factors and disposal.

With the CE marking, the manufacturer, distributor or EU authorized representative declares in accordance with EU Regulation 765/2008 that the product complies with the applicable requirements. Protective gloves are covered by the PPE Regulation EU 2016/425 and/or the Medical Devices Regulation 2017/745. The attached number indicates which “Notified Body” (independent, accredited testing body) has tested the glove.

This symbol indicates that the glove is made of latex material (natural rubber) or contains latex. A latex allergy can cause severe symptoms if left untreated and can even lead to life-threatening anaphylactic shock.
The instructions for use must be observed. They can be found either on the packaging or as an insert in it.
If the latex symbol is crossed out, the glove does not contain latex material (natural rubber). These gloves are suitable for latex allergy sufferers.
This standard describes all the test methods to be used and the general requirements relating to design principles, glove manufacture, resistance of the glove material to water penetration, harmlessness, comfort and performance, and specifies the marking to be applied by the manufacturer and the information to be provided by the manufacturer.
The product must be protected from heat and direct sunlight.
If a disposable glove complies with European Standard 455, this means that it is approved for use in the medical sector. The European Standard (EN) 455 is divided into four different requirements (EN 455-1 to EN 455-4).
The product must be protected from moisture.
Acceptable Quality Level (AQL) is the maximum number of defective (leaking) gloves of a lot or batch in percent (performance level/AQL). For medical gloves, an AQL of max. 1.5 is prescribed in the EN 455-1 standard.
The product should be stored in the specified temperature range.
The EN ISO 374-1:2016 standard specifies the properties of gloves for protection against chemicals and/or microorganisms in three type classes (A, B ,C). The gloves are tested for penetration, permeation and degradation.
PAP designates the recyclable material group cardboard and paper. The number can be used to distinguish whether the material is corrugated board (20), other paperboard (21) or paper (22).
The EN ISO 374-5:2016 standard explains protection against microorganisms. The pictogram for biohazard is used for gloves for protection against bacteria and fungi. For this purpose, the protective glove must be tested for freedom from leakage (resistance to penetration) in accordance with EN ISO 374-2:2014.
A manufacturer outside the EU must appoint an EU authorized representative to represent it externally. This is defined in the European Regulation 2017/745. The EU authorized representative is available to the authorities within the EU as a contact person on behalf of the manufacturer.
EN ISO 374-5:2016 incl. virus: For protection against bacteria, fungi and viruses, the glove must pass the penetration test according to EN ISO 374-2:2014. If protection against viruses is also required, a bacteriophage penetration test must also be performed and passed in accordance with ISO 16604:2004 (method B).
The abbreviation “EXP” (expiration date), indicates the date from which the shelf life of the product can no longer be guaranteed.
Gloves with this pictogram are suitable for handling foodstuffs according to Regulation 1935/2004/EEC. This means that under normal conditions they do not transfer any components that are hazardous to health to the foodstuffs (migration) and that they do not affect the odor and taste of the product.
The batch designation enables products or production batches to be traced back to the producer, ingredients or special manufacturing process and product characteristics over the entire supply chain or in sections.
Medical devices with the crossed-out “2” are intended for single use only. They are not intended to be reused.
A reference number (item number) establishes a reference to the product and allows the product to be clearly assigned.
MD stands for Medical Device Regulation and indicates that it is a medical device as defined by Regulation 2017/745.
The Pharmacy Central Number (PZN) is a nationwide identification code for drugs, medical products and other common pharmacy products in Germany.
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