CERTIFICATE

CERTIFICATE
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CERTIFICATE

Product catalog summary
Introduction
This report evaluates a category III Personal Protective Equipment (PPE) filtering half mask, designed to protect against particles, in compliance with PPE Regulation 2016/425 and EN 149:2001 + A1:2009 standards.
Certification and Compliance
The EU Type-Examination Certificate, issued by APAVE Sudeurope SAS (notified body 0082), confirms compliance with essential health and safety requirements for FFP2 NR class masks, both valveless (SA1500) and with a valve (SA1510), produced by AEREM INDUSTRY CO LTD.
Technical Specifications
The masks are constructed from polypropylene and rubber, intended for single-shift use. They feature a foldable design, a nose clip of high-density polyethylene, and self-adjusting ear loops. The filter media includes three layers of polypropylene and one layer of polyethylene ethylene-propylene.
Use and Limitations
These masks are designed for respiratory protection against particles, not for escape purposes, and are disposable after a single use.
Technical Documentation
Documentation provides detailed descriptions of mask components, CE marking, and packaging. The CE mark is clearly printed on the mask's exterior.
Examination and Testing
The masks underwent visual inspection, packaging, material suitability, practical performance, and total inward leakage tests, passing all to confirm their protective effectiveness.
Specifications and Test Results
  • Filter Penetration: Meets maximum penetration requirements for sodium chloride and paraffin oil tests for FFP1, FFP2, and FFP3.
  • Skin Compatibility: Materials do not cause skin irritation.
  • Flammability: Does not burn for more than 5 seconds post-flame removal.
  • CO2 Content: Inhalation air's CO2 content is below 1.0% volume limit.
  • Breathing Resistance: Meets maximum resistance for inhalation and exhalation at various flow rates.
  • Clogging Resistance: Tested for clogging resistance, with specific requirements for valved and valveless masks.
Marking and Information
  • Packaging and Mask Marking: Includes manufacturer identification, type, classification, and standards.
  • Instructions for Use: Provided in the official language(s) of the destination country, covering application, limitations, and maintenance.
Conclusion
The filtering half mask meets the essential health and safety requirements of PPE Regulation 2016/425 and EN 149:2001 + A1:2009, with conformity to the manufacturer's technical documentation.
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Catalog excerpts

CERTIFICATE-1

In enforcement of Regulation 2016/425 of the European Parliament and of the Council th of 9 March 2016 on Personal Protective Equipment and repealing the Directive 89/686/EEC and in compliance with the Module B Certification Scheme of Apave 'M.MEPI.45' in force, En exécution du Règlement 2016/425 du Parlement Européen et du Conseil du 9 mars 2016 relatif aux Equipements de Protection Individuelle et abrogeant la Directive 89/686/CEE et en respect du Programme de Certification Module B de l'Apave 'M.MEPI.45' en vigueur, APAVE Sudeurope SAS, notified body identified under number 0082, awards the APAVE Sudeurope SAS, organisme notifié identifié sous le numéro 0082, attribue l’ EU TYPE-EXAMINATION CERTIFICATE Attestation d’examen UE de type N° 0082/3857/079/02/21/0094 The following PPE type complies with the applicable essential health and safety requirements Le type de l'EPI suivant est conforme aux exigences essentielles de santé et de sécurité applicables PPE category III – Filtering half mask to protect against particles with and without exhalation valve EPI de catégorie III – Demi-masque filtrant contre les particules avec et sans soupape expiratoire Trademark: EFAS PROTECT Marque commerciale This certificate is awarded to the 2 following references: La présente attestation est attribuée aux 2 références suivantes : - SA1500 – Specificity : valveless Spécificité : sans valve - SA1510 – Specificity : with valve Spécificité : avec valve Manufacturer: Fabricant AEREM INDUSTRY CO LTD - Workshop No.54 - Road 1-7 - Long Thanh IZ - TAM AN COMMUNE - Long Thanh District - Dong Nai Pr - Vietnam Authorised representative: Aeremn Industry Sp. Zo.o.- UI.Lubczynska 6F 70-895 SZCZECIN - Poland Mandataire Filtering half mask to protect against particles class FFP2 NR with or without exhalation valve in polypropylene and rubber for single shift use only. The half mask is foldable with a vertical fold flat shape, designed with a noseclip in high-density polyethylene iron platine zinc and two self-adjusting ear loop in nylon and spandex. The filter media is composed of three layers in polypropylene and electret masterbatch and one layer in polyethylene ethylene-propylene sidebyside (detailed description in EU type examination report 20.1900). Demi-masque filtrant contre les particules classe FFP2 NR avec ou sans soupape expiratoire en polypropylène et caoutchouc à usage unique. Le demi-masque est de forme plate à pliage verticale, conçu avec une barrette nasale en haute densité poyethylène et deux brides auto-réglables en nylon et spandex portées derrière les oreilles. Le média filtrant est composé de trois couches en polypropylène et une couche en polyéthylène éthylène-propylène sidebyside (description détaillée dans le rapport d'examen UE de type 20.1900). Technical referential in use: EN 149 : 2001 + A1 : 2009 Référentiel technique utilisé Date of signature (day/month/year): 11/02/2021 Date de signature (jour/mois/année) Date of issue (day/month/year): PPE Certification Manager Le Responsable de la Certification EPI Immaterial original Signatur e Date de délivrance (jour/mois/année) Date of renewal (day/month/year): first edition Date de renouvellement (jour/mois/année) Accréditation N° 5-0596 Scope available on Portée disponible sur www.cofrac.fr Date of expiry (day/month/year): Date d’expiration (jour/mois/année) For category III PPE, the certificate shall only be used in conjunction with one of the conformity assessment procedures referred in point c) of Article 19 Pour les EPI de catégorie III, l'attestation ne doit être utilisée qu'en liaison avec l'une des procédures d'évaluation de la conformité visées à l'article 19, point c). The manufacturer shall inform the notified body of all modifications to the approved type and of all modifications of the technical documentation that may affect the conformity of the PPE with the applicable essential health and safety requirements or the conditions for validity of that certificate (article 7.2 – annex V) Le fabricant informe l'organisme notifié de toutes les modifications du type approuvé et de toutes les modifications de la documentation technique qui peuvent remettre en cause la conformité de l'EPI aux exigences essentielles de santé et de sécurité applicables ou les conditions de validité de cette attestation (article 7.2 – annexe V) This certificate includes one page - C

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CERTIFICATE-2

APAVE SUDEUROPE SAS, organisme notifié, identifié sous le numéro 0082 APAVE SUDEUROPE SAS, notified body, identified under number 0082 Centre d’Essais de Fontaine 17, Boulevard Paul Langevin 38600 FONTAINE - France Tél. +33.(0)4.76.53.52.22 Fax +33.(0)4.76.53.32.40 AEREM INDUSTRY CO LTD Workshop No.54 - Road 1-7 - Long Thanh IZ TAM AN COMMUNE - Long Thanh District - Dong Nai Province Vietnam PPE REGULATION 2016/425 – ANNEX V MODULE B – EU TYPE EXAMINATION ASSESSMENT REPORT Respiratory protective device Report n° Technical referential EN 149 : 2001 + A1 : 2009 PPE category III Filtering half mask...

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CERTIFICATE-3

1. Introduction - Description of the service 2. Use of the report 3. Economical operator(s) 4. Identification of the equipment 5. Conditions for use of the equipment 6. Reference specification 7. Technical Documentation 8. Correlation between the articles of PPE Regulation 2016/425 and the reference standard 9. Examination report 10. Conclusion

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CERTIFICATE-4

1.Introduction - Description of the service This assessment report concerns PPE category III – Filtering half mask to protect against particles with and without exhalation valve as defined in EN 149 : 2001 + A1 : 2009. Its purpose is to assess the conformity of the PPE with the PPE REGULATION 2016/425, with a view to be placed on the European market exclusively. The assessment was conducted in accordance with purchase order signed on 24/11/2020 placed by Aeremn Industry Sp. Zo.o. for the count of AEREM INDUSTRY CO LTD. Company: AEREM INDUSTRY CO LTD - Workshop No.54 - Road 1-7 - Long Thanh IZ...

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