PROTECTIVE GLOVES

Kondrat and Partners
legal aid in the market introduction of protection measures against Covid – 19 – biuro@kondrat.pl

 

MEDICAL GLOVESCa
tegory: personal protective equipment

 

Legal requirements

The legal requirements for this product category are set out in:

  • Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment,
  • Act of 26 June 1974 Labour Code,
  • Act of 30 August 2002 on the conformity assessment system,
  • Annex II to the Regulation of the Minister of Labour and Social Policy of 26 September 1997 on general health and safety at work.
Conditions of sale in Poland
  • carrying out the conformity assessment procedure in accordance with Regulation 2016/425 on personal protective equipment,
  • preparation by the manufacturer of a declaration of conformity for compliance with the health and safety requirements set out in Regulation 2016/425 on personal protection (the competent notified body should be involved in the conformity assessment process),

 

A model declaration of conformity is given below:

 

EU DECLARATION OF CONFORMITY

 

  1. PPE (product number, type, batch or serial number):

 

  1. Name and address of the manufacturer and, where applicable, of his authorized representative:

 

  1. This declaration of conformity shall be issued under the sole responsibility of the manufacturer:

 

  1. Subject of the declaration (identification of PPE enabling traceability; a sufficiently clear colour illustration may be included where this is necessary for the identification of PPE):

 

  1. The subject matter of this declaration described in point 4 shall comply with the relevant requirements of Union harmonisation legislation: …

 

  1. References to the relevant harmonised standards which have been applied, together with the date of the standard, or to other technical specifications, together with the date of the specifications for which conformity is declared:

 

  1. Where applicable, the notified body … (name, number) … carried out an EU type-examination (Module B) and issued an EU type-examination certificate … (reference to this certificate).

 

  1. Where appropriate, PPE shall be subject to a conformity assessment procedure … (either type compliance based on internal production control and supervised product inspections at random intervals (module C 2) or type conformity based on production process quality assurance (module D)) … under the supervision of the notifier … (name, number).

 

  1. Additional information:

 

Signed on behalf of: …

 

(place and date of issue):

 

(name, position) (signature):

 

Compliance with standards

Gloves to protect against biological agents such as viruses, bacteria and fungi classified as category III personal protective equipment under Regulation (EU) 2016/425 shall comply with the requirements set out in the following standards:

  • EN ISO 374-5:2016 (PL-EN ISO 374-5:2017-02) Gloves to protect against hazardous chemicals and microorganisms. Part 5: Terminology and requirements for the risk of microbial penetration,
  • EN 420:2003+A1:2009 (PN-EN 420+A1:2012) Protective gloves. General requirements and test methods.

In addition, protective gloves may meet the requirements of one or more of the following standards:

  • ASTM F1671/F1671M-13 (USA),
  • ABNT NBR ISO 374-5:2018-01-16 (South America),
  • GB 28881-2012 (China),
  • AS/NZS 2161.10.1:2005 (Australia and New Zealand),
  • GOST 12.4.278:2014 (Russia),
  • JIS L 1902:2015 (Japan).
Documents required for the sale of protective gloves
  • a declaration of conformity for compliance with the health and safety requirements set out in Regulation 2016/425 on personal protection,
  • a certificate for the product confirming that the product complies with the above-above standards.
Marking of protective gloves

The outer packaging of protective gloves should contain the following information:

  • CE marking,
  • type name, batch or batch number or other information enabling PPE to be identified (where the size or nature of ppe does not allow it— the required information shall be included on the packaging or in the document accompanying the PPE),
  • the manufacturer's details, name, registered trade name or registered trade mark and the postal address at which he can be contacted (if it is not possible to appear on ppe — the manufacturer's data shall be indicated on the ppe packaging or in the document accompanying the PPE)
  • the importer's particulars , in the case of imported protective gloves, i.e. the name, registered trade name or registered trade mark and the postal address at which the importer can be contacted (if it is not possible to place on ppe, the importer's data shall be affixed to the PPE packaging or in the document accompanying the PPE),
  • in accordance with the requirements of the standards indicated as
Purchase procedure of the Ministry of Health

Due to the prevailing pandemic, specific arrangements have been provided for the supply of personal protective equipment and medical devices.

The Ministry of Health has introduced a special purchasing procedure under which products can be purchased in accordance with the guidelines of the national consultant in the field of infectious diseases.

In accordance with this procedure:

  • it is possible to sell protective gloves before the conformity assessment is completed and without the CE marking,
  • however, protective gloves must comply with the guidelines of the national consultant, including in particular as regards the above-above standards,
  • the outer/packaging must include:
  • information that the product may only be used during an increased epidemic and epidemic period, but not more than 30 days after the end of the epidemic in relation to SARS-CoV-2 infections, and
  • manufacturer's details (name and address),
  • gloves may only be used for healthcare personnel, including sanitation, services and other persons involved in the action against the coronavirus epidemic,
  • the glove marking must state that the product may only be used during periods of increased epidemic and epidemic risk but not more than 30 days after the end of the epidemic in relation to SARS-CoV-2 infections and the manufacturer's details (name, address).
Rules for the export of gloves abroad
  • not later than 36 hours before the intention to export or dispose of the protective goggles outside the territory of Polish shall be notified of the intention of the governor responsible for the trader's registered office or place of residence, giving a list and quantity of products,
  • the governor may or may not submit an application to the Prime Minister to prohibit the export or disposal of these products outside the territory of Polish.
VAT rate

As a general rule, medical devices and PPE are subject to a 23% or 8% VAT rate. The amount of the rate depends on the assignment of the product to the correct final grouping of the PKWiU.

In accordance with the provisions of the Regulation of the Minister of Finance of 25 March 2020. on goods and services for which the rate of tax on goods and services is reduced and the conditions for the application of reduced rates, it is possible to apply a reduced rate of 0% of the tax in the case of the free transfer by a taxable person of goods belonging to his undertaking, in particular any donations of personal protective equipment – only masks, face guards/windows, goggles, safety goggles, overalls, shoe protectors, caps and gloves.

However, certain conditions must be met for the application of the reduced VAT rate (the donation must be made in writing, between the donor and one of the entities enumerated in the legislation, it must be clear from the contract that the goods delivered will be used by the rightholders).

The reduced rate of VAT can therefore be applied to donations made under the above conditions between 1 February 2020 and 31 August 2020.

 

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