Regulation and Standards

Regulation and Standards

Cleanroom Gloves Control & Standard

AIBON manufactures disposable and other rubber-made gloves that adhere to various standards. We specialize cleanrooms quality and protection standards against microorganisms or chemicals. Our team applies references, like 

  • ISO 21420:2020+A1:2022 
  • ISO 374-1:2016+A1:2018
  • ISO 374-5:2016
Cleanroom Gloves Control & Standard
Chemical Exposure

Chemical Exposure

ISO 374-1:2016+A1:2018, P1. Term for performance standards on chemical threats. (Gloves that prevent harmful substances, including microorganisms)

EN 16523-1:2015+A1:2018, P1. Liquid chemical infusion in continued exposure. (Material penetration resistance on chemicals)

ISO 374-2:2019, P2. Resistance to penetration  (Gloves that protect against microbes and other toxic elements)

ISO 374-4:2019, P4. Degradation resistances cause by chemicals. (Protective gloves that offer defense from bacterium and other dangerous compounds)

Biological Risk

ISO 374-2:2019

P2. Determining durability on penetration.

Provide prevention of microorganisms and other hazardous toxins.

ISO 374-5:2016

P5. A label that specifies threats caused by microorganisms 

Ensure safety over submicroscopic organisms and other damaging contaminants.

ISO 16604:2004 (Procedure B)

Validation of PPE’s tolerance response to blood-borne pathogens

Protective clothing equipment that prevents exposure of body fluid or blood

Biological Risk
Mechanical & Radioactive Risk

Mechanical & Radioactive Risk

EN 388:2016+A1:2018: Mechanical risk-resistant gloves protection against: 

  • Blade cut
  • Puncture & Tear
  • Abrasion and other related impacts 

Testing Use: Pictogram- It indicates the gloves’ level of protection against this threat. They’ll show up to four digits and two letters representing their performance level. 

EN 421:2010Designates gloves resistant to contamination by radioactive or ionizing radiation.

Medical Applications

EN 455-1:2020

Scope: P1. Medical single-use gloves must pass tests to ensure they are free of holes.

EN 455-2:2015

Scope: P2. Medical disposable gloves should undergo evaluations of their physical qualities.

EN 455-3:2015

Scope: Single-use gloves need to go through biological testing for medical use. 

EN 455-4:2009

Scope: One-use gloves must undergo testing to determine their shelf-life.

Medical Applications
ASTM D257-07Standard Test Methods
  • Conductance of Insulating Materials
  • DC Resistance
ASTM D257-36
ASTM D6319-10Standard Specification
  • Nitrile Examination Gloves (Medical Use)
ASTM D3767-03Standard Practice 
  • Measurement of Dimensions for Rubbers
ASTM D6124-06Standard Test Method
  • Medical Gloves  Residual Powder
ASTM D6978-05Standard Practice 
  • Assessment of Resistance to Permeation on Chemotherapy Medicine 
ASTM D573-04 Standard Test Method
  • Deterioration in an Air Oven on Rubber
Directive 72/2002/EC
  • Related to Products Made of Plastic and Those Meant to be Used with Food
ISO 21171:2006
  • Measuring the Amount of Removable Coated Powder on Medical Gloves
  • Usage of Gloves and Finger Cots in Cleanrooms and Other Regulated Environments
ISO 9001:2015
  • Standards for Quality Management Systems

One Stop Gloves OEM Manufacturer

AIBON provides a one-stop gloves OEM soulution for our customers, we won't let you down!
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