BIOSAFE PF P SIDE GLOVE S/PS

Typology
Latex glove, disposable, non-sterile, free from lubricating powder, white colour, internal lining in synthetic polymers, anatomical shape, ambidextrous, textured surface, with reinforced anti-rolling elastic 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 in implementation of EEC Directive 89/686.
Certification certificate 0162/11126/06–00610C

Intended use
Protection from biological agents, from accidental contact with chemical substances, suitable for use in examinations, therapy, diagnostics, laboratories, cleaning, the chemical industry, workshops, food processing.
Suitable for hospital and outpatient use.

Device size

CUT	ITEM NUMBER	PALM WIDTH	MIN. LENGTH
XS/5-5.5 S/6-6.5 M/7-7.5 L/8-8.5 XL/9-9.5	ARPFGXS extension DARPFGS extension DARPFGM extension DARPFGL extension ARPFGXL	≤ 80mm 80±10mm 95±10mm 110±10mm ≥110mm	240mm 240mm 240mm 240mm 240mm

Certifications and tests
The Biosafe PF Plus glove was tested on behalf of the manufacturing company for the purposes of defining quality, specificity, sensitivity and safety for the operator and for the patient:
• test for compliance with EN 455 I-II-III-IV (AQL for absence of holes, dimensions, physical properties, biological safety, determination of shelf life);
• test for compliance with EN 374 I-II-III (resistance to penetration and permeation by chemical substances and microorganisms);
• EN 388 test (resistance against mechanical risks);
• EN 420 test (general requirements);
• MOCA test (Materials and Objects intended for food contact) in compliance with the Regulations of the Ministerial Decree 21/03/73 and subsequent amendments
• global migration test in compliance with European Directive 72/2002/EEC;
• ASTM F 1671 – 1997 viral penetration test
• microbial load test;
• sensitization and skin irritation tests;
• tests for the determination of chemical residues;
• biocompatibility with ISO 10993 standards
The entire product manufacturing and marketing process 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 respected.

Specific storage and handling conditions and related methods
Storage: Keep out of direct sunlight, store in a cool and dry place. Keep away from ozone sources or flammable sources.
Cleaning: The gloves were not designed to be cleaned or washed.

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 reactions and/or contact allergies.
In the event of an allergic reaction, it is advisable to consult a doctor immediately.

Instructions for Use
These gloves are designed for single use.
For more information regarding the performance of each glove consult:
• the information printed on the package of the p