TECHNICAL SPECIFICATIONS

Surgical glove in pure natural rubber latex. The micro-rough surface ensures optimal grip, the anatomical shape guarantees maximum sensitivity. Finely powdered. Suitable for hospital, outpatient and dressing use.

The product is certified as a class IIa medical device. In compliance with the provisions of the GUIDELINES FOR THE DEFINITION OF SAFETY AND ENVIRONMENTAL HYGIENE STANDARDS OF OPERATING DEPARTMENTS drawn up by ISPELS, the gloves have been tested to define their ability to be a waterproof barrier and offer valid protection against viral agents. and potentially pathogenic microorganisms ensuring the impermeability of the gloves to body and blood fluids that may contain such pests.

The product has also been tested by the notified body CE0465 for protection from MECHANICAL, CHEMICAL AND BIOLOGICAL RISKS, in accordance with the provisions of LEGISLATIVE DECREE No. 475: implementation of Directive 89/686 / EEC Directive with reference to the provisions of the aforementioned guidelines ISPESL.

The product does not bear the marking as PPE in accordance with the current legislation which provides that surgical gloves are to be considered Medical Devices and does not allow a product to be simultaneously marked as a medical device and as an individual protection device (see Note Min. Health DGFDM III / P / 13228 / I 1c.r.)

REFERENCE STANDARDS:

Legislative Decree 37/2010, EEC Directive 93/42, Directive 47/2007

UNI EN ISO 11135, Italian Republic Pharmacopoeia X Ed., European Pharmacopoeia III Ed.

Legislative Decree no. 475/92, Legislative Decree 626/94, European Dir. 89/686 / EEC

EN 455 PART I - II - III, EN 374 PART I - II - III, EN 420, EN 388, ASTM F1671 B

ASTM F1670-98

ISO 2859

COMPOSITION:

Natural rubber latex> 90%

Talc:

Powdered with modified corn starch conforming to USP Current Ed. Specifications

STERILIZATION:

Through ETO. Sterility analysis according to USP ed.corr.

CONFIRMS WITH THE REGULATIONS:

EN 455-1 / UNI EN 374 / EN 455-2 / ASTM D412 / ASTM D573 / ASTM 3578 / EN 420 / ASTM 3578 / EN 420 / EN 374-2 / ​​EN 374-3 / ASTM F1670 / ASTM F1671 / EN 388 / ISO 10993-5 / ISO 10993-10 / ISO 10993-10 / En 455, EN 374, Italian Republic Pharmacopoeia, European Pharmacopoeia, USP Current Ed / Italian Republic Pharmacopoeia X Ed. / EN 455 Italian Republic Pharmacopoeia / European Phaarmacopoeia USP Current ed.

Packaging:

Pair packed individually