925 Disposable Granberg COATS Gloves User Manual

: June 7, 2024
: GRANBERG

Table of Contents

925 Disposable Granberg COATS Gloves
INTENDED USE
PRODUCT INSTRUCTION FOR USE
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925 Disposable Granberg COATS Gloves

PRODUCT-SPECIFIC INFORMATION ON THIS PAGE ONLY
Disposable Examination and Protective Gloves Granberg®. Nitrile, Colloidal Oatmeal, non-sterile, powder-free. Dawn blue colour.
EN ISO 21420:2020 ASTM D6978-05

Available sizes	XS	S	M	L	XL
5/6	6/7	7/8	8/9	9/10

EN ISO 374-1:2016+A1:2018

(Type B)

| Permeation

Performance Level

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

Mean Degradation, %

---|---|---|---
K| 40% Sodium Hydroxide| 6| > 480| -67.8
P| 30% Hydrogen Peroxide| 3| > 60| 20.3
T| 37% Formaldehyde| 5| > 240| -27.8

Chemotherapy Drugs tested by ASTM D6978-05

Chemotherapy Drug by ASTM D6978-05| Minimum breakthrough detection time in minutes
---|---
Carmustine (BCNU), 3.3 mg/ml (3,300 ppm)| 24.1
Cisplatin, 1.0 mg/ml (1,000 ppm)| > 240
Cyclophosphamide (Cytoxan), 20 mg/ml (20,000 ppm)| > 240
Dacarbazine, 10.0 mg/ml (10,000 ppm)| > 240
Doxorubicin HCl 2.0 mg/ml (2,000 ppm)| > 240
Etoposide, 20.0 mg/ml (20,000 ppm)| > 240
Fluorouracil, 50.0 mg/ml (50,000 ppm)| > 240
Methotrexate, 25 mg/ml (25,000 ppm)| > 240
Mitomycin C, 0.5 mg/ml (500 ppm)| > 240
Paclitaxel, 6.0 mg/ml (6,000 ppm)| > 240
Thiotepa, 10.0 mg/ml (10,000 ppm)| 25.2
Vincristine Sulfate, 1.0 mg/ml (1,000 ppm)| > 240

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 374-4:2019, EN ISO 374-5:2016.
Notified Body responsible for EU Type Examination (Module B) and for quality assurance of the production process (Module D): SATRA Technology Europe Ltd. (NB No. 2777), Bracetown Business Park, Clonee, D15YN2P, Republic of Ireland.
This product is classified as a Class I Medical Device according to Annex VIII 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
User Manual issue date : 11.01.2024
Head office : GRANBERG AS, Bjoavegen 1442, 5584 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
granberggloves.com

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 with Colloidal Oatmeal are intended for use in the medical field to protect patients and users from cross-contamination. It also contributes to moisturizing theskin of the user. These gloves are also intended to protect against certain chemicals, and microorganisms 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, PRECAUTIONS AND CONTRAINDICATIONS 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 374-4:2019) 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. Do not use if the glove is visibly torn, frayed or damaged. Change glove after each patient. Always select the correct size glove for your hand. 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. Components used in glove manufacturing may cause allergic reactions in some users. If allergic reactions occur, seek medical advice immediately. The use of the device is contraindicated for medical conditions which require an examination, a diagnostic or therapeutic procedure on breached/ compromised skin and /or under sterile conditions. 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. ASTM D6978-05- Gloves used for protection against chemotherapy drug exposure should be selected specifically for the type of chemicals being used. Due to the variety and concentration of chemotherapy drugs used in treatments, the resistance table shown does neither warrant nor imply the safe use of gloves against chemotherapy drug resistance in every case. The safe use of the glove in chemotherapy treatment is solely the decision of clinicians authorized to make such a decision.

PRODUCT INSTRUCTION FOR USE

Before use, after donning, and during use inspect the gloves for any defects 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. 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 intoeach 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 comes off. 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

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 occurs 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/cm2/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).

Permeation Performance Level| Measured Breakthrough Time (minutes)
---|---
0| *
1| > 10
2| > 30
3| > 60
4| > 120
5| > 240
6| > 480