GranberG 630 Disposable Protective Gloves User Manual

GranberG 630 Disposable Protective Gloves

Product Information

Product Specifications:

• Standard: ISO 374-1/Type B
• Compliance: ISO 374-5:2016, EN 421:2010, MDR (EU) 2017/745, PPER (EU) 2016/425
• Sizes Available: S, M, L, XL
• Chemical Resistance: K 40% Sodium Hydroxide, P 30% Hydrogen Peroxide, T 37% Formaldehyde
• Permeation Performance Level: 6 2 5
• Latex Free: Yes
• Classification: Category III Personal Protective Equipment, Class I Medical Device

Product Usage Instructions

• 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, microorganisms, and radioactive contamination where hand protection is needed.

• Size Options:
  Choose from sizes available: S, M, L, XL.

• Chemical Resistance:
  These gloves are resistant to various chemicals including Sodium Hydroxide, Hydrogen Peroxide, and Formaldehyde. Refer to the provided chemical resistance data for each chemical.

• Usage Precautions:
  Use gloves only for their intended purpose. Avoid using damaged or expired gloves. Do not reuse disposable gloves.

• Disposal:
  After use, dispose of the gloves according to hospital policy and local regulations as they may be contaminated.

• Reporting Incidents:
  In the event of a serious incident related to the use of the gloves, report it to the manufacturer and the competent authority.

Frequently Asked Questions

Q: Are these gloves latex-free?

A: Yes, these gloves are latex-free.

Q: What standards do these gloves comply with?

A: These gloves comply with standards including EN ISO 21420:2020, EN ISO 374-1:2016+A1:2018, EN ISO 374-5:2016, and EN 421:2010.

Q: How should I choose the correct size?

A: Refer to the size options provided (S, M, L, XL) and choose the size that best fits your hand measurements.

PRODUCT-SPECIFIC INFORMATION

Disposable Examination and Protective Gloves Magic Touch® by Granberg. Nitrile, non-sterile, powder-free. Violet blue color.

EN ISO 21420:2020 ASTM D6978

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| -25.7
P| 30% Hydrogen Peroxide| 2| > 30| 44.8
T| 37% Formaldehyde| 5| > 240| -17.1

Chemotherapy Drugs tested by ASTM D6978.

Chemotherapy Drug under ASTM D6978| Minimum breakthrough detection time in minutes
---|---
Carmustine (BCNU), 3.3 mg/ml (3,300 ppm)| 14.7
Cisplatin, 1 mg/ml (1,000 ppm)| > 240
Cyclophosphamide (Cytoxan), 20 mg/ml (20,000 ppm)| > 240
Dacarbazine (DTIC), 10 mg/ml (10,000 ppm)| > 240
Doxorubicin Hydrochloride, 2 mg/ml (2,000 ppm)| > 240
Etoposide (Toposar), 20 mg/ml (20,000 ppm)| > 240
Fluorouracil, 50 mg/ml (50,000 ppm)| > 240
Methotrexate, 25 mg/ml (25,000 ppm)| > 240
Mitomycin C, 0.5 mg/ml (500 ppm)| > 240
Paclitaxel (Taxol), 6 mg/ml (6,000 ppm)| > 240
Thiotepa, 10 mg/ml (10,000 ppm)| 39.4
Vincristine Sulfate, 1 mg/ml (1,000 ppm)| > 240

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, microorganisms, and radioactive contamination, 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 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 are 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 of 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.

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. These gloves do not protect against mechanical risks and ionizing radiation. Do not use it if the glove is visibly torn, frayed, or damaged. Change gloves 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 that require an examination, a diagnostic or therapeutic procedure on breached/compromised skin, and/or under sterile conditions. Persons who are known to be sensitive to chemical additives should consider using this glove. Where relevant, a list of substances contained in the glove that are known to cause allergies, listed in Annex G of EN ISO 21420:2020, shall be supplied on request.

ASTM D6978 – 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 into each glove finger. Pull by the glove palm to get a good fit. Don the other glove by the same procedure.
• Doffing, hold the 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. Recommended to store at room temperature prevailing in respective countries. 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 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, and Type C > level 1 for 1 chemical (no code under pictogram).

• A: Methanol
• B: Acetone
• C: Acetonitrile
• D: Dichloromethane
• E: Carbon disulfide
• 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%

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

Indicates that the glove falls below the minimum performance level as stated in EN ISO 374-1:2016+A1:2018 for the given individual hazard.

Additional information on chemical resistance is obtainable from the manufacturer.

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 374-5:2016, EN 421:2010 (excluding clause 4.3).
• 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 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.

• 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.

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