Biosafe PF Plus RAYS 100 Powder Free Latex Gloves Size M

Biosafe PF Plus RAYS Powder Free Latex Gloves Size M

BIOSAFE PF PLUS

POWDER-FREE LATEX EXPLORATION GLOVES

Latex glove, disposable, non-sterile, free of lubricating powder, white color, internal lining in synthetic polymers, anatomical shape, ambidextrous, textured surface, with reinforced elastic anti-rolling cuff.

CE marking

• Medical device - class I (Dir. 93/42 / EEC); pursuant to Legislative Decree 37/2010 in implementation of Dir. 2007/47 / EEC
• Personal Protection Device - III category, CE 0465 pursuant to Legislative Decree 475/92 implementing Directive EEC 89/686.
• Certificate of certification 0162/11126 / 06–00610C

Intended use

Protection from biological agents, from accidental contact with chemicals, suitable for use for examination, therapy, diagnostics, laboratory, cleaning, chemical industry, workshops, food processing.
Suitable for hospital and outpatient use.

Dimensions of the device

Certifications and tests

The Biosafe PF Plus glove has been tested on behalf of the manufacturing company to define quality, specificity, sensitivity and safety for the operator and for the patient:

• tests for compliance with EN 455 I-II-III-IV (AQL for absence of holes, dimensions, physical properties, biological safety, determination of the shelf life);
• test for compliance with EN 374 I-II-III (resistance to penetration and permeation by chemicals and microorganisms);
• EN 388 test (resistance against mechanical risks);
• EN 420 test (general requirements);
• MOCA test (Materials and Objects intended for Food Contact) in accordance with the Regulation of the Ministerial Decree 21/03/73 and subsequent amendments
• global migration test in compliance with the European Directive 72/2002 / EEC;
• test for viral penetration ASTM F 1671 - 1997
• microbial load test;
• skin sensitization and irritation test;
• tests for the determination of chemical residues;
• biocompatibility to ISO 10993 standards

The entire production and marketing process of the product is ISO 9001 and ISO 13485 certified.

Period of validity

The normal life of a powder-free latex examination glove is 5 years, provided that the storage instructions are followed.

Specific conditions of storage and handling and relative methods

Storage: keep away from direct sunlight, store in a cool and dry place. Keep away from ozone sources or flammable sources.

Cleaning: The gloves are not designed to be cleaned or laundered.

Risks

Biosafe PF Plus gloves contain latex, known as a possible cause of allergy for certain types of sensitive people, who could therefore develop irritation and / or contact allergy reactions.

If an allergic reaction occurs, it is advisable to consult a doctor immediately.

Instructions for Use

These gloves are designed for single use.

For more information on the performance of each glove, see:

• the information printed on the product packaging;
• the manufacturer Rays spa.

Precautions

Before use, check that each glove is free from defects or imperfections. If in doubt, discard the glove and replace it with another one.

If gloves are used in contact with chemicals:

• avoid direct contact of the chemical substance with the skin, even if this substance is declared as harmless;
• the gloves are designed for protection against accidental splashes or brief contact. In case of accidental contact with the skin, wash thoroughly with soap and water;
• gloves that have been placed in contact with chemicals should be removed and thrown away as quickly as possible;
• make sure that the chemical cannot come into contact with the skin via the cuff.

Gloves should not be used in applications requiring protection against mechanical or thermal risk.

Quality controls in production and on the finished product

The manufacturer has established and currently carries out a number of procedures to ensure that the product is identified, controlled and tested for compliance with a number of specific requirements.

Packaging

100 gloves / box - 10 boxes / carton.

The gloves are packaged in dispensers of 100 pieces, arranged in such a way as to allow the extraction of only one glove at a time through the appropriate opening.

The 10 dispensers are placed in cartons so that the smaller side of the dispenser is at the top of the carton.
This is in order to maintain the integrity of the dispenser during transport.

Disposal

Used gloves may be contaminated with infectious agents or other hazardous materials. Disposal must be carried out in compliance with the national regulations in force.

Incineration or landfill must be carried out under controlled conditions.

Format

Box of 100 gloves Size M