GRANBERG Category III and Medical Device Disposable Gloves User Manual
- June 2, 2024
- GRANBERG
Table of Contents
USER MANUAL FOR DISPOSABLE GLOVES
CATEGORY III and MEDICAL DEVICE
Category III and Medical Device Disposable Gloves
PRODUCT-SPECIFIC INFORMATION ON THIS PAGE ONLY
Disposable Examination and Protective Gloves Granberg, nitrile, non-
sterile, powder-free, black.
EN ISO 374-1:2016+A1:2018 (Type B)| Permeation Performance
Level| Measured Breakthrough
T ime (minutes)| EN ISO 374-4:2019
Mean Degradation, %
---|---|---|---
A| Methanol| 0| < 10| 71.0
J| n-Heptane| 0| < 10| 57.0
K| Sodium Hydroxide 40%| 6| > 480| -60.0
L| Sulphuric Acid 96%| 0| < 10| 100.0
N| Acetic Acid 99%| 0| < 10| 98.0
O| Ammonium Hydroxide 25%| 1| > 10| 83.9
P| Hydrogen Peroxide 30%| 2| > 30| 14.3
T| Formaldehyde 37%| 2| > 30| 34.7
Permeation by chemical in accordance with ISO 18889:2019
| Chemical | Test Method | Requirement | Test Results |
|---|---|---|---|
| EC-DY (surrogate pesticide) diluted solution | ISO 19918:2017 | ≤10 μg/cm² | Pass |
The User Manual should be used with product-specific information.
User Instructions should be read before using.
INTENDED USE
Powder-free examination and protective disposable nitrile gloves are intended for use in the medical field to protect patients and users from cross- contamination. These gloves are also intended to protect against certain chemicals, specified low risk solvents, microorganisms and diluted pesticides where hand protection is needed. Foodstuff-approved gloves are marked with relevant food pictograms and comply with relevant EU Regulations. Gloves should be used only according to their intended purpose.
WARNINGS AND PRECAUTIONS OF USE
This information does not reflect the actual duration of protection in the
workplace and the differentiation between mixtures and pure chemicals and
other factors influencing the performance such as temperature, abrasion,
degradation etc. The chemical resistance has been assessed under laboratory
conditions from samples taken from the palm only (except in cases where the
glove is equal to or over 400 mm – where the cuff is tested also) and relates
only to the chemical tested. It can be different if the chemicals 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 a dangerous chemical 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. Degradation
levels (EN ISO 374-4) indicate the change in puncture resistance of the gloves
after exposure to the challenge chemical. The penetration resistance has been
assessed under laboratory conditions and relates only to the tested specimens.
ISO 18889:2019: The duration of the test is not based on actual usage time
since the permeation test is an accelerated test in which the surface of the
specimen is in constant contact with the testing chemical. Although the
duration of the exposure may be for a longer period during field application
with a diluted formulation, the entire surface is not in constant contact with
the testing chemical. Check the minimum overlap. If the overlap is less than
approximately 50 mm between the glove and the sleeve, a glove with longer
length should be used.
Remove the glove immediately if contaminated by a concentrate spill.
PRODUCT INSTRUCTION FOR USE
Before use, after donning, and during use inspect the gloves for any defect or
imperfections and discontinue use immediately if signs of tearing, swelling or
degradation, or any damage appear. Dry hand before donning. Ensure chemicals
or residuals cannot enter through the cuff. Change glove after each patient.
Always select the correct size glove for your hand. For donning, hold the
glove by the bead with one hand. Align the glove thumb with your other hand
thumb and slide your hand into the glove, one finger into each glove finger.
Pull by the glove palm to get a good fit. Don the other glove by the same
procedure. Doffing, hold glove bead and pull toward the finger until the glove
come off. For Single Use only. If re-used, the risk of contamination and
infection increases due to improper cleaning processes; and increased risk of
holes and tear during re-use due to weakening of gloves by cleaning processes.
Ill-fitting gloves will greatly reduce dexterity and cause fatigue. Using the
wrong glove size leads to inadequate hand protection. When an indication for
hand hygiene precedes a contact that also requires glove usage, hand rubbing
or hand washing should be performed before donning gloves and after removing
gloves.
DISPOSAL
Used gloves can be contaminated and must be disposed of under hospital policy
and/or local regulation.
INGREDIENTS/HAZARDOUS COMPONENTS
Components used in glove manufacturing may cause allergic reactions in some
users. If allergic reactions occur, seek medical advice immediately. Where
relevant, a list of substances contained in the glove that are known to cause
allergies, per listed in Annex G of EN ISO 21420:2020, shall be supplied on
request.
STORAGE
Store in a cool and dry place in its original package. Opened boxes should be
kept away from fluorescent and sunlight. Keep the gloves away from ozone,
heating devices, and the source of the fire. The shelf life for products
stored as recommended is mentioned on each package. Service life cannot be
specified and depends on the application and responsibility of the user to
determine the suitability of the glove for its intended use.
REPORTING OF INCIDENTS
In case of any serious incident occurred with the use of this device, please
report it to the manufacturer and the competent Authority.
Further information can be obtained from the manufacturer, please contact
Granberg AS.
EXPLANATION OF SYMBOLS AND PICTOGRAMS USED
Protective gloves against dangerous chemicals and microorganisms – Part 1:
Terminology and performance requirements for chemical risks. EN ISO
374-1:2016+A1:2018. Definition of breakthrough time through the glove palm (1
µg/cm /min).
Type A > level 2 for 6 chemicals, Type B > level 2 for 3 chemicals, Type C >
level 1 for 1 chemical (no code under pictogram).
| 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%
---|---|---
Additional information on chemical resistance obtainable from manufacturer.
Permeation Performance Level| Measured Breakthrough T
ime (minutes)
---|---
0| *
1| > 10
2| > 30
3| > 60
4| > 120
5| > 240
6| > 480
| Protection against bacteria,
fungi and viruses| | Lot number| | Caution
---|---|---|---|---|---
| Protection against bacteria and
fungi, not tested against viruses| | Fragile, handle with care| | Raw material
latex
| Protection against pesticides. G1-
Gloves are suitable when the potential risk is relatively low. These gloves
are not suitable for use with concentrated pesticide formulations and/or for
scenarios where mechanical risks exist.| | Keep away from sunlight| | Do not
contain natural rubber
| Suitable for contact with foodstuffs.
Note: not all gloves that are suitable for handling food may be suitable for
all types of food. Check the Food Declaration of Compliance.| | Keep dry| |
Corrugated cardboard
| Manufacturer| | Temperature limit| | Non-corrugated paperboard
| Date of manufacture| | Do not reuse| | Paper
| Expiry date| | Check User Instruction| | Medical Device
Unique Device Identifier
Article number
Latex free: yes.
This product is Category III Personal Protective Equipment as per Regulation
(EU) 2016/425 and complies with standards: EN ISO 21420:2020, EN ISO 374-
1:2016+A1:2018, EN ISO 374-2:2019, EN 16523-1:2015+A1:2018, EN ISO 374-4:2019,
EN ISO 374-5:2016, ISO 18889:2019. Notified Body responsible for EU Type
Examination (Module B): SATRA Technology Europe Ltd. (NB No. 2777), Bracetown
Business Park, Clonee, D15YN2P, Republic of Ireland. Notified Body responsible
for Quality Assurance of the Production Process (Module D): SGS Fimko Oy (NB
No. 0598), Takomotie 8, FI-00380 Helsinki, Finland.
This product is classified as Class I Medical Device according to Annex VIII
of the Regulation 2017/745 and complies with standards: EN 455-1:2020, EN
455-2:2015, EN 455-3:2015, EN 455-4:2009, ISO 15223-1:2021.
Declaration of Conformity:
www.granberg.no/search
Head office: GRANBERG AS,
Bjoavegen 1442, 5582 Bjoa, Norway.
Phone: +47 53 77 53 00,
E-mail: [email protected]| Swedish office: GRANBERG
SVERIGE AB,
Schubergsvägen 20, 311 74 Falkenberg, Sweden.
Phone: +46 (0) 346-124 25,
E-mail: [email protected]
---|---
User Manual issue date: 01.06.2022
granberggloves.com
Documents / Resources
|
GRANBERG Category III and Medical Device Disposable
Gloves
[pdf] User Manual
Category III and Medical Device Disposable Gloves, Category III Disposable
Gloves, Medical Device Disposable Gloves, Disposable Gloves, Gloves
---|---