GRANBERG Magic Touch Disposable Gloves Category III and Medical Device User Manual

: June 9, 2024
: GRANBERG

Table of Contents

Magic Touch Disposable Gloves Category III and Medical Device
Product Information:
Product Usage Instructions:
PRODUCT-SPECIFIC INFORMATION ON THIS PAGE ONLY
INTENDED USE
WARNINGS AND PRECAUTIONS OF USE
PRODUCT INSTRUCTION FOR USE
DISPOSAL
INGREDIENTS/HAZARDOUS COMPONENTS
STORAGE
REPORTING OF INCIDENTS
EXPLANATION OF SYMBOLS AND PICTOGRAMS USED
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Magic Touch Disposable Gloves Category III and Medical Device

Magic Touch Disposable Gloves Category III and Medical
Device

Product Information:

Product Code: 620 114.620
Powder-free and white in color
Available sizes: S, M, L, XL, 6/7, 7/8, 8/9, 9/10
Chemical Resistant Gloves tested in accordance with EN ISO 374-1:2016+A1:2018 (Type B) standards
Laboratory gloves tested in accordance with ASTM D6978-05 for use with chemotherapy drugs
Category III Personal Protective Equipment as per Regulation (EU) 2016/425
Class I Medical Device according to Annex VIII of the Regulation (EU) 2017/745
Latex-free product

Product Usage Instructions:

Select the appropriate glove size for your hand.
Open the package and remove the gloves.
Put on the gloves ensuring a snug fit.
Use the gloves for tasks requiring protection against chemicals and/or chemotherapy drugs.
Discard the gloves after use according to your facility’s regulations.

Note: These gloves are not recommended for use with Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) and Thiotepa 10.0 mg/ml (10,000 ppm) chemotherapy drugs. Please follow proper handling procedures when using hazardous chemicals and/or chemotherapy drugs.

PRODUCT-SPECIFIC INFORMATION ON THIS PAGE ONLY

Disposable Examination and Protective Gloves Magic Touch® by Granberg. Nitrile, non-sterile, powder-free. White colour.

EN ISO 374-1:2016+A1:2018

(Type B)

| Permeation

Performance Level

| Measured Breakthrough Time (minutes)| EN ISO 374-4:2019

Mean Degradation (%)

---|---|---|---
| *4% Chlorhexidine Digluconate| 6| > 480| 19.0
K| 40% Sodium Hydroxide| 6| > 480| -42.9
| 10-13% Sodium Hypochlorite| 6| > 480| 14.7
| 50% Sulphuric Acid| 6| > 480| -20.5
| 10% Acetic Acid| 4| > 120| 66.7
| 5% Ethidium Bromide| 6| > 480| 3.4
T| 37% Formaldehyde| 3| > 60| 5.0
M| 65% Nitric Acid| 0| < 10| 97.6
| 50% Glutaraldehyde| 6| > 480| 27.4
| 0.1% Phenol| 6| > 480| 33.8
P| 30% Hydrogen Peroxide| 2| > 30| 22.8
| 1.5% Methanol in water| 6| > 480| 21.9
| 70% Isopropanol| 0| < 10| 62.2
| 35% Ethanol| 0| < 10| 38.8
N| 99% Acetic Acid| 0| < 10| 93.9
O| 25% Ammonium Hydroxide| 0| < 10| -52.0
| 3% Povidone-iodine| 6| > 480| 33.7
| 10% Sodium Percarbonate| 6| > 480| 15.4
Chemotherapy Drug in accordance with ASTM D6978-05| Minimum breakthrough detection time in minutes
---|---
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm)| Not Recommended
Cisplatin 1.0 mg/ml (1,000 ppm)| > 240
Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm)| > 240
Cytarabine 100 mg/ml (100,000 ppm)| > 240
Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm)| > 240
Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm)| > 240
Etoposide (Toposar) 20.0 mg/ml (20,000 ppm)| > 240
Fluorouracil 50.0 mg/ml (50,000 ppm)| > 240
Ifosfamide 50.0 mg/ml (50,000 ppm)| >240
Methotrexate 25.0 mg/ml (25,000 ppm)| > 240
Mitomycin C 0.5 mg/ml (500 ppm)| > 240
Mitoxantrone 2.0 mg/ml (2,000 ppm)| > 240
Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm)| > 240
Thiotepa 10.0 mg/ml (10,000 ppm)| Not Recommended
Vincristine Sulfate 1.0 mg/ml (1,000 ppm)| > 240

Latex free: yes.
This product is Category II 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 374-4:2019, EN ISO 374-5:2016. Notified Body responsible for EU Type Examination (Module B) and for internal production control plus supervised product checks at random intervals (Module C2): SATRA Technology Europe Ltd. (NB No. 2777), Bracetown Business Park, Clonee, D15YN2P, Republic of Ireland. This product is classified as Class I Medical Device according to Annex VIll of the Regulation (EU) 2017/745 and complies with standards: EN 455-1, EN 455-2, EN 455-3, EN 455-4, IsO 15223-1:2021. EU Declaration of Conformity: www.granberg.no/search

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, micro organisms 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 wokplace 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 374-4:2019) 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.

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. Poorly- 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. Gloves are packed in a dispenser box suitable for transport. Keep the gloves in the box when not in use. 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 ug/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).