SHARING EXPERTISE
Surgical Glove
Instruction Manual
Glove for single use compliant with PPE regulation (EU) 2016/425, EN 420, and EN ISO 374
INSTRUCTIONS FOR USE
Instructions for use are to be used in combination with the specific product-related information on each product packaging. The gloves are sold as a bundled unit within the shipping carton. In case this bundled unit is dismantled and products are sold separately, the distributor must ensure that the instructions for use are accompanied by each separate unit.
The gloves are classified as Personal Protective Equipment (PPE) Category III according to PPE Regulation (EU) 2016/425 and have been shown to comply with this regulation through the applicable harmonized European standards. These gloves are designed to provide protection against specific chemicals tested, microorganisms, and particulate radioactive contamination (if applicable). The gloves meet the EN/ISO standards shown on each specific packaging. This PPE is single-use only and is to be disposed of after contamination.
EXPLANATION OF STANDARDS AND PICTOGRAMS
EN ISO 374-1
Permeation levels are based on breakthrough times (tested acc. EN 16523-1:2015) as follows:
Type A / B / C
Permeation level acc. EN ISO 374-1:2016 +A1:2018
Minimum breakthrough time in minutes
| 1 | 2 | 3 | 4 | 5 | 6 |
| 10 | 30 | 60 | 120 | 240 | 480 |
ABCDEFGHIJKLMNOPST
Type A = chemical breakthrough time > 30 minutes against at least 6 chemicals from the list
Type B = chemical breakthrough time > 30 minutes against at least 3 chemicals from the list
Type C = chemical breakthrough time > 10 minutes against at least 1 chemical from the list
TEST CHEMICALS:
A = Methanol / B = Acetone / C = Acetonitrile / D = Dichloromethane / E = Carbon disulphide / F = Toluene / G = Diethylamine /
H = Tetrahydrofuran / I = Ethyl acetate / J = n-Heptane / K = Sodium hydroxide 40 % / L = Sulphuric acid 96 % / M = Nitric acid 65 % /
N = Acetic acid 99 % / O = Ammonium hydroxide 25 % / P = Hydrogen peroxide 30 % / S = Hydrofluoric acid 40 % /
T = Formaldehyde 37 %
EN 374-4:2013
The degradation (in %) indicates the change in puncture resistance of the gloves after exposure to the respective challenge chemical.
This information does not reflect the actual duration of protection in the workplace and the differentiation between mixtures and pure chemicals. The chemical resistance has been assessed under laboratory conditions from samples taken from the palm only and relates only to the chemical tested. It can be different if the chemical is used in a mixture. It is recommended to check that the gloves are suitable for the intended use because the conditions at the workplace may differ from the type test depending on temperature, abrasion, and degradation. When used, protective gloves may provide less resistance to dangerous chemicals due to changes in physical properties. Movements, snagging, rubbing, degradation caused by chemical contact, etc. may reduce the actual use time significantly. For corrosive chemicals, degradation can be the most important factor to consider in the selection of chemical-resistant gloves. Before usage, inspect the gloves for any defects or imperfections.
EN ISO 374-5: 2016
Tested for resistance to penetration according to EN 374-2:2014
Tested for resistance to penetration by blood-borne pathogens according to EN ISO 374-5 / ASTM F1671 (virus resistance).
Resistance to bacteria and fungi – pass
Resistance to the virus – pass
The penetration resistance has been assessed under laboratory conditions and relates only to the tested specimen.
XXXX = Identification number of notified Body responsible for the EU-type examination and supervising ongoing conformity.
PRECAUTIONS FOR USE
Always check the gloves for possible mechanical damage, e.g. holes or tears, before use. Do not use damaged gloves. Glove length is appropriate to the end user where the risk to the wrist area is minimal.
TEMPERATURE LIMIT
STORAGE INSTRUCTIONS
Keep storage area cool, dry, and dust free, avoid ventilation and storage close to photocopy equipment. Protect gloves against ultraviolet light sources, sunlight, oxidizing agents, and ozone. Store in original packaging according to the temperature limit provided on the packaging.
EN 421:2010
Protection against particulate radioactive contamination.
These gloves do not protect against mechanical risks.
PPE is for single-use only and must not be reused.
EN 420:2003+A1:2009
Before usage read instructions for use carefully.
INGREDIENTS / HAZARDOUS INGREDIENTS
Some gloves might contain ingredients that are known to possibly cause skin irritations or allergic reactions in sensitized persons. Check warning information on specific packaging carefully. The formulation is available on request.
DISPOSAL INSTRUCTIONS
Dispose of the gloves in accordance with the valid regulations for this material.
Gloves contaminated with chemical substances must be disposed of in accordance with the regulations for the relevant chemicals.
B. Braun Melsungen AG
www.bbraun.com
B. Braun: A leading medical technology company
