Перчатки смотровые (диагностические) APEXMED Clemas виниловые, нестерильные, неопудренные, гладкие, универсальные (на обе руки); цвет: белый, размеры: XS, S, M, L, XL — инструкция и характеристики

РУ: РЗН 2016/4334 от 28.06.2016 · класс риска 1

Производитель: "Апексмед Интернэшнл Б. В." (Нидерланды)

Вид изделия: Перчатки смотровые/процедурные виниловые, неопудренные

Автоматически отфильтрованный фрагмент инструкции по применению (страницы, где похоже, что есть таблица технических характеристик) — не полный документ. Карточка РУ на портале Росздравнадзора →

Текст инструкции: технические характеристики

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т APEXMED
(Р
Examination Gioves (Diagnostic) APEXMED 
Ciemas, Vinyl, Nonsterile, Powder Free
Operating Manual
Apexmed International bv 
Kelzersgracht 62-64 
1015 CS Amsterdam 
The Netherlands
t +31 (0)20 520 7560 
f +31 (0)20 520 7510 
e 
info@apexmed.nl 
w www.apexmed.eu
Bank ING
IBAN € NL96INGB0674235010 
IBAN $ NL34INGB0020286279 
BIG INGBNL2A
KvK 34159173 Amsterdam 
BTW 810618114-B01


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1. Intended Use.
Examination gloves (diagnostic) APEXMED vinyl, nonsterile, powder 
free are intended to protect patients and medical personnel from cross­
contamination during various procedures. The device serves as protection 
barrier wearing on personnel hands during patient's examination/treatment 
or for other sanitary purposes. The device protects medical personnel and 
patients hands from contaminations. The gloves are resistant to blood im­
pact, semen or cervical secretions, other biological liquids and chemical 
agents.
2. Indications for gloves applications.
• possible contact with blood;
• contact with semen or cervical secretions;
• contact with the mucous membranes of the nose, mouth, genitals, 
rectum;
• contact with a biological fluid, regardless of the blood presence;
• contact with objects or materials contaminated with blood or other 
body fluids;
• any violation of the integrity of the skin of the patient or medical 
personnel;
• possible contact with the patient's bedding;
• laboratory tests.
3. Contraindications to the use of gloves
Allergic skin reactions such as contact dermatitis may be caused by the 
components used in the pro-duction of vinyl gloves.
In the case of allergic reactions / contact dermatitis product, immediately 
discontinue use and consult a doctor.
4. Safety Measures.
- All manipulations connected with risk of hands contamination with blood 
or serum or chemical agents, must be performed with gloves;
- All injures on hands must be covered with plaster, watertight dressing;
- In case of skin contamination with blood it must be cleaned as soon as 
possible considering patient's safety:
- take off the gloves;
- treat the skin with pad, wet with 70% alcohol;
- wash the skin with soap and dry with swab;
- repeat treatment with 70% alcohol.
5. Working Principle.
Examination gloves (diagnostic) APEXMED vinyl, nonsterile, powder free 
are intended to protect patients and medical personnel from cross­
contamination during various procedures.


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The device serves as protection barrier, impervious for biological agents, 
wearing on personnel hands during patient's examination/treatment or for 
other sanitary purposes. The device protects medical personnel and pa­
tients hands from contaminations. The gloves are resistant to blood im­
pact, semen or cervical secretions, other biological liquids and chemical 
agents.
6. Main Characteristics.
Examination (diagnostic) gloves APEXMED Clemas, vinyl, non-sterile, pow­
der free, smooth, ambidextrous (for both hands), color: white, sizes: XS, S, 
M, L, XL.
Size table
Medical device name
Size Width,
mm
Length, 
min (mm)
Thickness, 
min (mm)
Examination (diagnostic) gloves 
APEXMED Clemas, vinyl, non-sterile, 
powder free, smooth, ambidextrous 
(for both hands), color: white, sizes: 
XS, S, M, L, XL
XS 76 ± 3
240
Fingers:
0.12±0,02
Palm:
0.10±0,02
Cuff:
0.10±0,02
s 84 ± 3
M 94 ± 3
L 105 ± 3
XL 113 ± 3
Thickness of the Corolla gipve (mm) 0,j.2±0,09
The weight of one glove (g) 4-5,5
Materials applied for production of examination (diagnostic)  
gloves APEXMED vinyl, nonsterile, powder free:
The components of the gloves:
• polyvinyl chloride (PVC) - colorless, transparent plastic, a thermoplastic 
polymer of vinyl chloride. Different chemical resistance to alkalis, mineral 
oils, many acids and solvents. Off the air and has a low resistance to frost;
• atsetiltributitsitrat (ATVS) - colorless transparent Jew-bone. Secure plasti­
cizer mainly used for PVC, cellulose resins and synthetic rubber. It is also 
used as a stabilizer of PVC;
3


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• calcium-zinc stabilizer - a complex inorganic substance used as a stabi­
lizer in the PVC manufacturing;
• paraffin oil - a high boiling petroleum distillate, mineral wax and resins of 
various origin containing more or fewer paraffin. It is used for the prepara­
tion of lubricants or, after a preliminary chemical purification of sulfuric ac­
id and alkali;
• polyurethane - hetero-polymer. It refers to the synthetic-sky elastomers, 
widely used in industry for a wide range of strength characteristics. It used 
as substitutes for the manufacture of rubber products, in aggressive envi­
ronments in conditions of high alternating loads and temperatures;
• PW6 (6Titanium dioxide (Pigment White)) - inorganic co-unity, fine, white 
powder. Used in the production-stve rubber and rubber goods rubber mat­
ting.
strength and airtightness requirements
No. Medical device name Strength testing results Airtightness testing 
results
1 Examination (diagnostic) gloves 
APEXMED Clemas, vinyl, non- 
sterile, powder free, smooth, ambi­
dextrous (for both hands), color: 
white, sizes: XS, S, M, L, XL
Before enhanced ageing: 
force at break: min 9 H, 
elongation at break: min 
450%,
After enhanced ageing: 
force at break: min 7 H, 
elongation at break: min 
400%
when gloves are 
filled with 1000 ml 
water there is no 
leakage.
7. Work order with medica examination (diagnostic) gioves
1. Treat hands.
2.
3.
Open the box, take a pair of gloves and unfold the pack.
Take glove for right hand by flap preventing touching of inside glove 
surface.
4. Close fingers of the right hand and insert them into the glove.
5. Put on the gloves not disturbing its flap opening fingers of the right 
hand.
6. Take the left glove with 2nd, 3rd and 4th fingers of the right hand (in 
glove) by the flap preventing touching of inside glove surface.
Close fingers of the left hand and insert them into the glove.
Smooth flaps on the left and then on the right hand pulling them on the 
sleeves.
Steps o f taking o ff the gloves
1. To make a cuff on the left glove by the fingers of the right hand, 
touching only the outside (preventing contamination of the forearm
7
8
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skin or sleeves of the gown if gloves cover the lower part of the 
sleeves).
2. Take off the glove from the left hand, inverting it inside out and hold­
ing the cuff. Keep it in the right hand (preventing contamination of 
the environment).
3. To take the left glove by the left hand by the cuff on the inside (pre­
venting contamination of the left hand).
4. Take off the glove from the right hand, inverting it inside out so the 
left glove appeared in the middle of the right (preventing contamina­
tion of the environment, providing infectious safety)
5. To put the gloves in the disinfectant solution (preventing distribution 
of microorganisms in the environment)
6. Perform hand hygiene treatment.
8. Disinfection and Disposal.
According to the current regulations, disposable gloves are subject to 
disinfection and disposal after use.
Immediately after use medical gloves are took off and immersed in 
disinfectant solution directly in the place of use. For this purpose the 
following solutions are used: 6% hydrogen peroxide, 3% solution of 
bleach, 1.5% sodium hypochlorite, calcium 2% solution lizoformita 3000. 
Exposure to these disinfectants is 60 minutes.
After disinfection disposable gloves must be disposed.
Examination gloves (diagnostic) vinyl, nonsterile, powder free are biohaz­
ard waste. Treatment and utilization according to the set rules must be 
performed.
Gloves utilization is performed by means of packs, bags and containers 
similar to utilization of dressing materials, after preliminary disinfection.
It is permitted to burn vinyl gloves. Vinyl gloves can be disposed this way 
without any harm to environment or human health.
The class of hazard medical wastes based on the characteristics of mor­
phological composition of class В (epidemiologically hazardous waste). 
Operation environment.
Operating Conditions
- For single use
- The temperature from + 35 °C to 10 °C
- Relative humidity; from 60% to 80%
- Atmospheric pressure 700gPa to 1060gPa
- Protect from moisture and direct sunlight 
Storage
- The temperature from +5 to -i-30 ° C


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- Relative humidity: from 60% to 80%
- Atmospheric pressure 700gPa to lOGOgPa
- Protect from moisture, direct sunlight and ionizing radiation
- Storage to use in packaging
- Storage 5 years 
Warranty
The manufacturer guarantees the safety of all the properties viewing 
gloves (diagnostic) APEXMED latex, non-sterile,powdered for 5 years from 
the date of production, if the integrity of the packaging and storage condi­
tions are observed 
Transport conditions
Glove boxes are transported in vehicles covered by any type of transport in 
accordance with the applicable rules and regulations of cargo transporta­
tion by this type of transport, at a temperature of -10 to -ь 40 ° C
9. Handling.
Transportation of the packed gloves should be carried out by all kinds of 
transport in covered vehicles in accordance with the rules of transportation 
of goods, applicable to each type of transport. Transportation by rail is car­
ried out by the container shipments.
10. Manufacturer:
«Apexmed International B.V.»
Keizersgracht, 62-64, 1015 CS Amsterdam, the Netherlands 
www.aDexmed.nl.www.sensitec.nl
Production Sites: Apexmed International B. V., Keizersgracht, 62-64, 
1015 CS Amsterdam, the Netherlands.
TG Medical Sdn. Bhd., Lot 5091 Jalan Teratai, Batu 5, off Jalan Meru, 
41050 Klang, Selangor D.E., Malaysia
11. Organization, authorized by the manufacturer on the  
acceptance and satisfaction of the requirements from consumers  
regarding products of inadequate quality: "Medicom Co., Ltd.", 
Russian Federation, 143570 Moscow region, Novopetrovskoe settlement, 
Pervomayskaya str., 59, Tel./Fax: л -1 (495) 651-91-16, email: medi- 
com@inbox.ru
Managing Director
l^ashid R. Biktogirov


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Name
Apexmed International B.V. 
Keizersgracht, 62-64,1015 CS, 
Amsterdam, the Neth^l^nds 
Managing Din 
Rashid R. Bi