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PPE Regulation

In February 2016, the European Council and European Parliament amended and approved a new PPE Regulation proposed by the European Commission. This New PPE Regulation will replace the original PPE Directive 89/686/EEC that was introduced in 1992. The new Regulation will now apply to private use as protection against heat (e.g., oven gloves) and to distributors selling PPE products. It provides additional conformity assessment requirements, such as the need for an internal production control system and valid Type-examination certificates for a maximum of 5 years. The Regulation also provides specific requirements for every economic operator involved in the supply chain, as well as additional documentation requirements linked to the Instructions for Use and Conformity Declarations.
The new PPE regulation now specifies three classes based on risk definitions. PERSONAL PROTECTIVE EQUIPMENT DIRECTIVE 7 Complying with New PPE Regulation

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Category I: Minimal Risk For gloves of simple design offering protection from low level risks, (e.g., janitorial gloves) manufacturers are permitted to test and certify gloves themselves.
Category II: Risks other than those listed in Categories I and III PPE designed to protect against intermediate risk (e.g., general handling gloves which require cut, puncture, and abrasion protection) must be subjected to independent testing and certification by a notified body. Only these approved bodies may issue a CE mark. Without a proper CE mark the gloves may not be sold or used. Each notified body has its own identification number. The name and address of the notified body that certifies the product must appear on the Instructions for Use that will accompany the gloves.

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Category III: Very serious risks, which may cause death or irreversible damage to health PPE designed to protect against the highest levels of risk (e.g., chemicals, biological agents, electric shock and live working) must also be tested and certified by a notified body. In addition, the quality assurance system used by the manufacturer to guarantee homogeneity of production must be independently checked. The body carrying out this evaluation must also appear on the Instructions for Use and be identified by a number that appears alongside the CE mark, in this case the number is 0493.

Standard EN420: 2003

Scope: This standard defines the general requirements for glove design and construction, innocuousness, comfort, efficiency, marking, and information applicable to all protective gloves.
Definition: A glove is an item of personal protective equipment that protects the hand or any part of the hand from hazards. It may also cover part of the forearm and arm. Performance levels show how a glove has performed in a specific test, and by which the results of that testing may be graded. Level 0 indicates that the glove is either untested or falls below the minimum performance level. Higher numbers indicate higher levels of performance. A performance level X means that the test method is not suitable for the glove sample.

Requirements: Glove construction and design

  • Gloves have to offer the greatest possible degree of protection in the foreseeable conditions of end use.
  • When seams are included, the strength of these seams should not reduce the overall performance of the glove.
  • The gloves themselves shouldn’t cause any harm to the user. pH of the glove should be between 3.5 and 9.5.
  • Chromium (VI) content should be below detection (< 3 ppm).
  • Natural rubber gloves shall be tested on extractable proteins as per EN 455-3.

Cleaning Instructions: If care instructions are provided, the levels of performance should not be reduced after the maximum recommended number of cleaning cycles.

Electrostatic Properties

  • Anti-static gloves that are designed to reduce the risk of electrostatic discharges shall be tested as per EN 1149.
  • Obtained test values are to be reported on the instructions for use.
  • An electrostatic pictogram shall NOT be used.

Water Vapour Transmission and Absorption:

  • If required, gloves shall allow water vapour transmission (5mg/cm2.h).
  • If a glove excludes water vapour transmission, it should be at least 8 mg/cm2 for 8 hours

Marking & Information Marking of the glove:

  • Each glove should be marked with: Name of manufacturer - Glove and size designation - CE mark - Appropriate pictograms accompanied by the relevant performance levels and the reference of the EN standard
  • The marking should be legible throughout the life of the glove. Where marking of the glove is not possible in view of the characteristics of the glove, it should be mentioned on the first packaging enclosure. Marking of the packaging immediately containing the gloves - Name and address of the manufacturer or representative
  • Glove and size designation
  • CE mark
  • Usage info - simple design: ‘For minimal risks only’ - intermediate design or complex design: relevant pictograms
  • When protection is limited to part of the hand, this shall be mentioned (e.g., ‘palm protection style only’).
  • Reference to where information can be obtained

Instructions for use:

  • Name and address of the manufacturer or representative
  • Glove designation
  • Size range available
  • CE mark
  • Care & storage instructions
  • Instructions and limitations of use
  • A list of all substances in the glove will be made available upon request
  • Name and address of notified body that certified the product

Glove Sizing Chart: Correct sizing is essential for ensuring glove comfort. The ideal way to determine glove size is with a dressmaker’s cloth tape. Use it to measure the circumference of the palm of the hand at its widest point (in mm or in inches). Cross reference that measurement against the table provided here. Measuring hands in this manner will not account for all possible variations in hand size. For instance, the length of a worker’s fingers may be longer or shorter than average. In that case, gloves that are one-half or even a full size larger or smaller than the measured hand size may fit more comfortably

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Standard EN388: 2016

Scope: This standard applies to all kinds of protective gloves in respect of physical and mechanical aggressions caused by abrasion, blade cut, puncture, and tearing.

Definition & Requirements: Protection against mechanical hazards is expressed by a pictogram followed by four numbers (performance levels), each representing test performance against a specific hazard, and two letters. The letter in the fifth position corresponds to an ISO Cut Resistance level. A letter “P” in the sixth position is for gloves certified to provide impact protection.

The ‘mechanical risks’ pictogram is accompanied by a 6-unit code (a-f).

  • a. Abrasion Resistance Based on the number of cycles required to abrade through the sample glove.
  • b. Blade Cut Resistance Based on the number of cycles required to cut through the sample at a constant speed.
  • c. Tear Resistance Based on the amount of force required to tear the sample.
  • d. Puncture Resistance Based on the amount of force required to pierce the sample with a standard-sized point.
  • e. ISO Cut Resistance Based on the force required to cut through a sample using a specified cut test machine (i.e., Tom dynamometer) under specified conditions.
  • f. EN Impact Protection Based on the measured transmission of energy and force when the sample experiences a dropped load.

Performance Level Rating

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Level X can also be applied for a – f above, which means “not tested” or “not applicable
These performance levels must be prominently displayed alongside the pictogram on the gloves and on the packaging that immediately contains the gloves.

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Standard EN407: 2004

Gloves giving protection from heat and/or fire hazards

Scope: This standard specifies thermal performance for protective gloves against heat and/or fire.

Definition & Requirements: The ‘heat and flame’ pictogram is accompanied by a 6-digit number:

  • a. Resistance to Flammability (performance level 0–4) Based on the length of time the material continues to burn and glow after the source of ignition is removed. The seams of the glove shall not come apart after an ignition time of 15 seconds.
  • b. Contact Heat Resistance (performance level 0–4) Based on the temperature range (100–500°C) at which the user will feel no pain for at least 15 seconds. If an EN level 3 or higher is obtained, the product shall record at least EN level 3 in the flammability test. Otherwise, the maximum contact heat level shall be reported as level 2.
  • c. Convective Heat Resistance (performance level 0–4) Based on the length of time the glove is able to delay the transfer of heat from a flame. A level of performance shall only be mentioned if a performance level 3 or 4 is obtained in the flammability test.
  • d. Radiant Heat Resistance (performance level 0–4) Based on the length of time the glove is able to delay the transfer of heat when exposed to a radiant heat source. A performance level shall only be mentioned if a performance level 3 or 4 is obtained in the flammability test.
  • e. Resistance to Small Splashes of Molten Metal (performance level 0–4) The number of molten metal drops required to heat the glove sample to a given level. A performance level shall only be mentioned if a performance level 3 or 4 is obtained in the flammability test.
  • f. Resistance to Large Quantities of Molten Metal (performance level 0–4) The weight of molten metal required to cause smoothing or pin holing across a simulated skin placed directly behind the glove sample. The test is failed if metal droplets remain stuck to the glove material or if the specimen ignites.

All EN407-rated gloves must also achieve at least performance level 1 for abrasion and tear

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Standard EN12477: 2001

Gloves giving protection from manual metal welding

Scope: This standard applies to protective gloves for use in manual metal welding, cutting, and allied processes.

Requirements: EN12477: Protective gloves for welders Standard for manual metal welding

Compliance with EN420 except for lengths:

  • 300 mm: Size 6
  • 310 mm: Size 7
  • 320 mm: Size 8
  • 330 mm: Size 9
  • 340 mm: Size 10
  • 350 mm: Size 11
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Type B gloves are recommended when high dexterity is required (e.g., TIG welding),
while Type A gloves are recommended for other welding processes. Type A or B is to
be marked on the product, its packaging, and in the instructions for use.

ISO 9001:2015

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ISO 14001:2015

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CE Certificate

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Industry Outlook Certificate

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Start Up India Certified

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