Lightweight Powder Free Nitrile Gloves

Classification:

Class I Medical Device, non sterile;

Personal Protective Equipment (PPE), category  III, for protection against chemicals and microorganisms.

Intended use: Classification as a Medical Device makes the product adapt for the following uses:

  • examination;
  • diagnostics;
  • therapy;
  • laboratory.

Classification as a DPI, makes the product adapt for the following uses:

- protection of the user in analysis laboratories, biology, cosmetics, etc

Product description: Single use nitrile gloves, ambidextrous with edge, without lubricant powder.

Normally, during the production process of the gloves, chemical additives are used to accelerate the polymerization process of the compound. Such substances (triazoles, thiurames and carbamates, sulfur), called accelerators, can cause type IV allergic reactions that can have delayed effects.

The particular technology called LOW DERMA ® which allows a formula free of these chemical substances, allows increased elasticity and resistance in the product, besides an extremely comfortable fit, particularly indicated for those who wear gloves for prolonged hours.

Particularly indicated in situations where continued use, comfort and maximum prevention against all types of allergies are elements of primary importance.

Characteristics and materials:

  • Nitrile (synthetic latex) “Accelerator free” meaning free of accelerator chemical substances. The LOW DERMA ® patented system allows complete absence of sulfur;
  • Highly biocompatible: particularly indicated for persons allergic to natural latex;
  • AQL < 1.5 (due to absence of holes);
  • Color: black dark blue;
  • Weight: 3.2 gr.  (size M);
  • External anti-slip finish and micro-rough at the tip of the fingers, to guarantee a safe and efficient grip;
  • Opaque internal finish;
  • Dispenser box: 100 pcs.
  • Dimensional Characteristics and sizes

Bar code

Size

Width (min)

mm.

Width (+/- 5)

mm.

979045352

XS / 5-5.5

240

75

979045364

S / 6-6.5

240

85

979045376

M / 7-7.5

240

95

979045388

L / 8-8.5

240

106

979045390

XL / 9-9.5

240

116

Thickness

Palm 0.07 mm.  (average thickness)

Breaking load (min.)

(ref. EN 455-2:2010)

6 N (before and after aging)

Breaking load (min.)

(ref. ASTM D 6319)

14 Mpa (before aging

Elongation at breakage

(ref. ASTM D 6319)

500 % (before aging)

 

Standards References:

  • Directive 93/42/CE for medical devices;
  • EU Regulations 2016/425 for individual protection devices which repeals directive 89/686/EEC of the  Council;
  • EN 455 1-2-3 - EN 374-1:2016 – EN 374-2:2014 – EN 16523-1:2015 (EN 374-3:2003+AC:2006) – EN 374-4:2013 - EN 374-5:2016 – EN 420-2003 + A1:2009;
  • Raw materials and productive process conform to FDA and GMP standard.