product specifications for powder free latex examination gloves

product specifications for powder free latex examination gloves

32 rue de Paradis – 75010 Paris - FRANCE
PRODUCT SPECIFICATIONS FOR POWDER FREE LATEX
EXAMINATION GLOVES
Material:
Description:
Natural Rubber Latex and compounding materials safe for use in medical gloves.
Ambidextrous, Beaded Cuff, Micro-textured, Chlorinated, Powder free, natural color
Standards of conformance:
Product conforms to the following test standards
EN 455-1
EN 455-2
EN 455-3
ISO 2859-1
Medical gloves for single use
Part 1: Requirements and testing for freedom from holes
Medical gloves for single use
Part 2: Requirements and testing for physical Properties
Medical gloves for single use
Part 3: Requirements and testing for biological evaluation
Sampling Procedures and Tables for inspection by Attributes
Conforms to the requirements of Medical Devices Directive 93/42/EEC in respect of the Essential Requirements (Annex 1) and
Annexes II, IV, V. This product is a Class I Non-invasive device for transient use (MDD Annex IX sections I (1.1) and III (1.1 rule 4)).
Performance Requirements
Physical Dimension
Physical Properties
FABRICANT SPECIALISE DANS LA VENTE DIRECTE DE PRODUITS DE SANTE
32 rue de Paradis 75010 Paris – France
SARL au capital de 9330 Euros – Siret: 487 829 905 00040 – Code NAF: 4646Z– TVA intracommunautaire: FR 93 487 829 905