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LATEX EXAMINATION GLOVES POWDERED EXTRA LARGE RAYS 1,0

Disposable powdered latex gloves Biosafe Plus Extra Large RAYS Italy
Manufacturer: Rays
SKU: 257-12-028

Disposable powdered latex gloves Biosafe Plus Extra Large RAYS

Disposable latex glove, non sterile, slightly powdered, white natural colour, ambidextrous, smooth surface, with reinforced anti rolling beaded cuff.

Brand name: BIOSAFE PLUS

Manufacturer: RAYS SPA

Item code: DAR EX + size
EC Marking: Medical Device - class I

Use:
Protection from biological agents, accidental contact with chemical substances, suitable for examination use, therapy, diagnostic laboratory, cleaning, chemical industry factories, food processing . Suitable for hospitals and day hospitals.

Aspect: ambidextrous, straight fingers, smooth textured, beaded cuff.
Powder : powder of cornstarch bio absorbable
Color: white
Glove thickness: palm mm 0.10 ± 0,02,fingertips mm 0.12 ± 0,02,cuff mm 0.06 ± 0,02
Packaging: 100 gloves per dispenser, 10 dispensers per carton.
Mechanical properties:

Tensile strenght (Mpa) Before Aging Min 3,6 After Aging Min 3,6

Elongation Before Aging Min 750% After Aging Min 750%

Force at break (N) Before Aging Min 10 After Aging Min 7,5

dimensions:

SIZEITEM CODEPALM WIDTHMIN. LENGTH
S / 6-6,5DAR EX S80 ± 10 mm240 mm
M / 7-7,5DAR EX M95 ± 10 mm240 mm
L / 8-8,5DAR EX L110 ± 10 mm240 mm
XL / 9-9,5DAR EX XL≥ 110 mm240 mm

ABSORBO Powder:
ABSORBO HP is a bio-absorbable powder conform to USP. It is obtained with special starch amid processing, conceived for the use as lubricant for surgical and examination gloves. Extra resistant against swelling caused by boiled water, vapour and chemicals organism. This product can be subjected to different sterilization proceeding without any particular effect on its features.
Characteristics and Benefits:
The ABSORBO powder meets all the requirements of Pharmacopoeia regarding the bio-absorbable powders, including the stability of the autoclave. Its versatility makes it useful in both dry and wet pulverization methods; it has excellent physical properties and is highly resistant to the action of heat during the inflation procedures in boiling water. When it is suspended in a liquid, the powder is separated into fine particles that are deposited uniformly on the surface, while continuing to operate as an excellent lubricant and an anti-bonding. Its physical characteristics and the fineness of the particles minimize wastage.

The powder ABSORBO is recommended as a lubricating agent for a variety of medical products, in particular for surgical gloves and examination. It is most efficient when applied in the form of aqueous suspension at 10-15% solid, but it can also be applied as a powder by hand.

Tests and Certifications:
BIOSAFE PLUS glove has been tested on behalf of the manufacturer in terms of quality definition, specificity, sensitivity, and safetyness for the user or the patient:
- Conformity Test for EN 455 I-II-III (AQL for lack of holes, dimensions, physical properties)
- Conformity Test for EN 374 I-II-III (resistance to penetration and permeation by chemical substances and microorganisms)
- Test EN 388 (resistant to mechanical risks)
- Test EN 420 (general requirements)
- Viral penetration test ASTM F 1671 – 1997
- Microbial test
- Sensitization and skin irritation test
- Chemical residue test
The entire process of production and marketing of the product is certified by ISO 9001 e ISO 13485.
Penetration resistance - EN 374- II – Micro biological Risk :
Test of air loss Passed
Test of water loss Passed

Validity:
The normal shelf-life of latex examination glove powder free is 5 years, considering that the storing instructions are respected.

Storage: keep the product away from the direct sunlight, keep the product in a fresh and dry place . Keep away from the ozone sources or ignition sources.
Cleaning: The gloves are not designed to be cleaned or washed.

Risks:
The BIOSAFE PLUS gloves contain latex, it is known as a possible cause of allergies to certain types of sensitive people, who could develop irritant reactions and / or contact allergy. In the event of an allergic reaction, you should consult a doctor immediately. The BIOSAFE PLUS powder free gloves contain natural vegetable source, known as a possible cause of allergies to certain types of sensitive people, who could develop irritant reactions and / or contact allergy. In the event of an allergic reaction, you should consult a doctor immediately.
Instructions for use:
These gloves are designed for single use and disposal of waste should be done on regular basis.
For further information of the glove performance will be consulted :
- The printed information on the package of the product.
- The manufacturer Rays Spa.
Precautions:
Before using the glove make sure that each glove is without defect or imperfection, in case of any doubt throw away the glove and replace it with another one.
If gloves are used in contact with the chemical substances:
- Avoid direct contact of chemical substance with skin even if that substance is declared harmless.
- Gloves have been manufactured for protection against accidental splashing or short contact. In case of accidental skin contact wash with plenty of water and soap.
- Gloves which had contact with any chemical substance, must be removed and thrown away as fast as possible.
- Make sure that no chemical substance comes into contact with skin by passing through the cuff.
- Gloves must not be used for the applications that request mechanical or heat protection.
Quality control in production and finished product:
The manufacturer stabilize and maintains variety of procedures in order to ensure that the product is identified, controlled and tested in conformity with variety of specific requirements.

Packaging:
100 gloves/box- 10boxes /carton
100 gloves are placed in the dispenser in order to guarantee the exact quantity and size and to respect to the Quality standards.
Once the dispenser is filled up with gloves, they are subject to the next control regarding the size and packaging integrity.
The 10 dispensers are placed in high quality cartons to be exported by sea. The smaller side of the dispenser is placed on the top side of the carton in order to keep the dispenser integrity during the transport both in pallet and container.

Disposal:
If the gloves get contaminated with infective agents or other potentially dangerous materials, they should be disposed in compliance with the current National regulations. The incineration or the disposal of the gloves must be performed under controlled conditions

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