Nitrile disposable gloves RAYS Biosoft Silk Medium
Disposable, nitrile, lubricant powder free, non sterile, anatomic ambidextrous, textured fingers. Internally chlorinated, light blue color, beaded cuff with high elasticity. The materials used in the production of gloves do not contain any substance that may be harmful or cause allergic reaction.
Commercial name: BIOSOFT SILK
Manufacturer: RAYS SPA
Product Code: DAR NI SILK + size
EC Marking: Medical Device - class I
Use:
Protection from the biological agents, accidental contact with chemicals, chemical resistance to concentrated detergents, detergents, hydrocarbons, ethers and Freon. Ideal for use of testing, treatment, diagnostic laboratory, cleaning, chemical industry, factories, food processing ,electronics. Suitable for hospitals and day hospitals. Thanks to its high biocompatibility and high ergonomic allows prolonged use without fatigue.
Aspect: ambidextrous, straight fingers, textured fingers, beaded cuff.
Color: light blue
Glove thickness: palm mm 0.05, Fingertips mm 0.08, cuff mm 0.04
Packaging: 200 gloves per dispenser, 10 dispensers per carton.
Mechanical Properties:
Tensile force (MPa) Before Aging Min 14, After Aging Min 14
Elongation Before Aging Min 400%, After Aging Min 300%
Force at break (N) Before Aging Min 3, After Aging Min 4
dimensions:
| Size | Article Code | Palm width | Min Length |
| XS / 5-5,5 | DAR NI SILK XS | ≤ 80 mm | 240 mm |
| S / 6-6,5 | DAR NI SILK S | 80 ± 10 mm | 240 mm |
| M / 7-7,5 | DAR NI SILK M | 95 ± 10 mm | 240 mm |
| L / 8-8,5 | DAR NI SILK L | 110 ± 10 mm | 240 mm |
| XL / 9-9,5 | DAR NI SILK XL | ≥ 110 mm | 240 mm |
Latex Free:
The materials used in the production of the gloves do not contain substances that may be harmful or cause allergic reactions. The gloves are deprived of latex components (latex free) and therefore particularly indicated for the staff who is sensitive to latex proteins and for use into latex free departments.
Lubricant system:
BIOSOFT SILK is powder free, internally chlorinated to allow easy use even with wet hands and to minimize the risk of allergic reactions.
The absence of powders allows the use of the glove by the people who suffer from the skin irritation caused by corn starch or by particularly sensitive skin.
Test and certifications:
BIOSOFT SILK has been tested on behalf of the producer for the purpose of quality definition, specificity, sensitivity, and the security for the operator 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)
- Test for viral penetration ASTM F 1671 – 1997
- Global Migration test conform with the European Directive 2002/72/EC
- Test for synthetic blood penetration, ASTM F 1670
- Microbial test
- Skin irritation and sensitization test.
- Test for chemical residues determination.
- Test for dust residues inside the glove- ASTM D 6214
- Tensile test for Medical Gloves ASTM D6319
The entire process of production and marketing of the product is certified by ISO 9001 e ISO 13485.
Validity:
The normal shelf-life of nitrile examination glove powder free is 3 years, given that the storing instructions were followed.
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.
Using Instructions:
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.
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 an other 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.
- The glove may have contact with: aqueous alimentary products, acids, alcohol and oils for which is foreseen the use of stimulants A, B, C, D for 1 hour at 40°C (in compliance with Directive 2002/72/CEE and s.m.i. and D.M. 21/03/73 and s.m.i.)
- 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 controls in production and on finished product.
The manufacturer defines and maintains a variety of procedures in order to ensure that the product is identified, controlled and tested in conformity with all specific requirements.
Packaging:
200 gloves/box- 10boxes /carton
200 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 gets 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 done under controlled conditions.
