GRANBERG Category III and Medical Device Disposable Gloves User Manual

: June 2, 2024
: GRANBERG

Table of Contents

Category III and Medical Device Disposable Gloves
INTENDED USE
WARNINGS AND PRECAUTIONS OF USE
PRODUCT INSTRUCTION FOR USE
REPORTING OF INCIDENTS
Documents / Resources

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: post@granberg.no| Swedish office: GRANBERG SVERIGE AB,
Schubergsvägen 20, 311 74 Falkenberg, Sweden.
Phone: +46 (0) 346-124 25,
E-mail: post@granberg-ab.se
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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
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