To protect you, an EPI. To protect them, a MD.
The hand is the first tool of man, indispensable, but also sensitive. To protect the skin from possible risks that can occur working in the Healthcare, LifeScience or Food Industry sector, the use of the protective glove is always necessary and, in some cases, even mandatory.
Deltalab has specialized in the manufacture and distribution of single-use sanitary products and laboratory equipment for more than 40 years and has several protective glove models within a very wide selection available in the Deltalab Catalogue.
Deltalab protective gloves are designed to provide health professionals and their patients with optimal conditions of protection, health, and hygiene.
In this article, we will try to illustrate clearly, what is the difference between an EPI glove, a MD glove, and a dual glove, and at the same time, show you all the specificities and characteristics of our Deltalab gloves made of latex or nitrile.
What is an EPI protective glove?
PPE (Individual Protection Equipment) are all devices or media designed and manufactured for use by a person for the purpose of protecting themselves from one or more health or safety risks.
How are they classified?
The PPE is regulated under EU Regulation no. 2016/425 and is classified according to the seriousness of the risk in question:
- Category I – protects against minimum risks.
- Category II – protects against moderate risks.
- Category III – protects against high risks (e.g., substances and mixtures hazardous to health and harmful biologicalagents). Deltalab gloves fall into this category.
Categories II and III must be certified by a Notified Organism in compliance with the EU Type Review, in addition to Production Control (Module C2) or Quality Control (Module D1).
What are the applicable regulations that EPI protective gloves must comply with depending on their application?
An PPE must also meet the following requirements:
- CE marking complies with EU Regulation 2016/425.
- The manufacturer must draw up an EU Declaration of Compliance with the applicable details.
- PPE labelling should report manufacturer data, product identification and batch number, and instructions for use and precautions necessary for proper use.
The following is the applicable regulations to be met by EPI protective gloves according to the intended purpose of the product:
- EN ISO 374-5: for a protective glove against microorganisms.
- EN ISO 374-1: for a chemical protection glove.
- EN ISO 374-2: for a protective glove without holes.
- ISO 16604: for a protective glove resistant to virus penetration.
- EN 16523: for a glove to protect against chemicals AND resistant to penetration.
What is a MD glove?
Un MD (Medical Device), is any instrument, device, or product, intended for human use for medical purposes and whose main action is not obtained by pharmacological means.
How are they classified?
A MD is characterized by maintaining a high level of innovation and safety in its use. Currently, approximately 500,000 different sanitary products are marketed around the world. These, sand classified according to your risk, degree of invasion and time of contact with the human body:
- Class I – considered low risk to the patient. The Deltalab sterile or non-sterile examination protection glove is located within this class.
- Class IIa – considered moderately risky to the patient. The surgical protective glove is located within this class.
- Class IIb – considered to be of potentially high/significant risk to the patient.
- Class III – considered to be of greatest risk to the patient.
The degree of invasion is measured by the introduction of the product into the body. It can be done by natural hole (through the ear, mouth, nostrils, etc.) or artificially, so the product would be considered surgically invasive.
The contact time differs by use transitory if the use is continuous for 60 minutes, short between 60 minutes and 30 days and prolonged use if use is continuous for more than 30 days.
What are the applicable regulations that MD protective gloves must comply with?
MD will be regulated under EU Regulation 2017/745 (MDR) from 26 May 2021, although Deltalab gloves already meet the requirements of this regulation.
A MD must meet the following requirements:
- CE marking in accordance with EU Regulation 2017/745 (MDR).
- The manufacturer must draw up an EU Declaration of Conformity with the applicable details.
- PS labeling should report manufacturer data, product identification and batch number, and instructions for use and precautions necessary for proper use.
In addition to the EU Regulation, MD protective gloves comply with the following harmonized standards:
- EN 455-1: no holes.
- EN 455-2: physical properties.
- EN 455-3: biological assessment.
- EN 455-4: determinate the shelf life.
What is a dual protective glove?
Protective gloves can fit in both categories: MD and EPI. This is the case, for example, of Deltalab gloves made of latex or nitrile, designed to protect both professionals and patients.
Deltalab protective gloves that respond to double use meet the requirements of both Regulations, as demonstrated on the packaging of the product.
Deltalab latex Protective Glove
Deltalab’s single use gloves, made of premium natural latex, are designed for medical, laboratory and industry use.
Available with or without dust to meet all details.
Manufactured according to the following standards:
- Class I Medical Device (MDR): Complies with EU Regulation 2017/745
- Individual Protective Equipment (Cat. III): Complies with EU Regulation 2016/425
Deltalab nitrile protective glove
Single-use Deltalab gloves made of blue nitrile are available without dust. They are designed for medical and laboratory use.
Manufactured according to the following standards:
- Class I Medical Device (MDR): Complies with EU Regulation 2017/745
- Individual Protective Equipment (Cat. III): Complies with EU Regulation 2016/425
Source: Diptych of the Ministry of Labour in relation to the use of dual protective gloves (EPI and Sanitary Product, 2019)