MASCHERINA PROTETTIVA FFP3 DPI di III categoria Codice articolo MP3-03

Mascherina protettiva FFP3 a conchiglia auto-filtrante per particelle e senza valvola. Comoda e pratica la nostra mascherina FFP3 ha 2 fasce di regolazione, in tessuto elastico privo di lattice, cucite all’esterno della mascherina e clip nasale. La mascherina FFP3 ha anche un rivestimento interno in poliuretano per garantire maggiore comfort ed una migliore adesione al viso. www.italsalus.com CERTIFICAZIONI → Dispositivo di Protezione individuale monouso → N95/ FFP3 con classe di protezione di Categoria III → Certificato di Conformità CE nel rispetto del Regolamento UE 425/2016 e D.Lgs 17/2019 → Standard di produzione nel rispetto dei regolamenti EN149:2001+A1:2009 - UNI EN149:2009 → Approvazione: FDA → Certificato di Conformità CE rilasciato da TÜV THÜRINGEN Shanghai Ltd. Room C6, Floor 16th Jiangsu Building, No 526 Laoshan Road, Shanghai 200122, P.R..CHINA → Ente Certificatore Europeo: ECM Ente Certificazione Macchine S.r.l. Via Cà Bella 243, 40053 Valsamoggia, (Bo) ITALY

CARATTERISTICHE → Mascherina a 5 veli con strato interno filtrante in tessuto “non tessuto” meltblown → Efficienza filtrazione ≥99% → Colori: bianco → Dimensioni 160mm x 110mm → Nome: HOPE&LIGHT → Fabbricante: Guandong Yulong Biomedical Technology Co. Ltd.

PACKAGING → Confezione da 20 mascherine confezionate singolamente → Cartone contenente 30 confezioni da 20 pz. → Dimensioni cartone cm 56,5 X 29,5 X 44 → Peso cartone Kg. 5,69 MASCHERINA PROTETTIVA FFP3 DPI di III categoria Codice articolo MP3-03 MASCHERINA PROTETTIVA FFP3 DPI di III categoria Codice articolo MP3-03 MASCHERINA PROTETTIVA FFP3 DPI di III categoria Codice articolo MP3-03

No. C.8621.2006.0101

Statement of Conformity

In compliance with the article 7(2) of the regulation EC No.1907/2006 of 18th December 2006, concerning the registration, evaluation, authorization and restriction of chemicals (REACh) GUANGDONG YULONG BIOMEDICAL TECHNOLOGY CO., LTD Applicant: ROOM 401, BUILDING 4, NO.2 XINGHUI ROAD, SONGSHANHU DISTRICT, DONGGUAN CITY, GUANGDONG PROVINCE, CHINA Manufacturer /

Product description Filtering half mask

Model No. YL003

Model May Cover /

Materials: /

Test report 8621.SH.2006.0101, 2020-06-11

Date of issue Jun.11, 2020

Conclusion: The statement of conformity is based on an evaluation of a sample of the above-mentioned product. Technical report and documentation are at the applicant’s disposal. This is to prove that the tested sample is in compliance with European Commission Regulation No.1907/2006 and its currently amendments on article 7(2) with substances content less than notification requirement: Article 7(2) Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met: (a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year; (b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w). Candidate list of substances of very high concern for authorization of REACh regulation in thresholds: https://echa.europa.eu/candidate-list-table And, this is only a verification based on the analysis of the product, component or materials, not on assessment of the products or the production procedure. If refers only to the sample submitted and does not certify the quality or safety of the serial products. After preparation of the necessary technical documentation as well as EU declaration of conformity the required CE making can be affixed on the product. Other relevant directives have to be observed. For and on behalf of

TUV Thuringen (Shanghai) Co., Ltd.

TUV THURINGEN (SHANGHAI) CO., LTD. ROOM C6, FLOOR 16TH JIANGSU BUILDING, NO.526 LAOSHAN ROAD, SHANGHAI 200122, P.R.CHINA E-mail: [email protected] website: http://www.tuv-thuringen.com.cn Copyright of this verification of conformity is owned by TUV THURINGEN (SHANGHAI) CO., LTD. And may not be reproduced other than in full and with the prior approval of the general manager.

MASCHERINA PROTETTIVA FFP3 DPI di III categoria Codice articolo MP3-03

TEST REPORT No. 8621.SH.2006.0101 Date: 06.11, 2020 Page: 1 / 12

Applicant : GUANGDONG YULONG BIOMEDICAL TECHNOLOGY CO., LTD ROOM 401, BUILDING 4, NO.2 XINGHUI ROAD, SONGSHANHU Address : DISTRICT, DONGGUAN CITY, GUANGDONG PROVINCE, CHINA

Below information submitted by the applicant:

Product Name : Filtering half mask Model : YL003 Model may cover : / Reference info. : / Manufacturer info. : / Supplier info. : / Buyer info. : / Country of Destination : Europe Country of Origin : China

Sample Received : 06.09, 2020 Test Period : 06.09, 2020 - 06.11, 2020 Test Requirement : Refer to next pages Test Method : Refer to next pages Test Result : Refer to next pages Test Conclusion : Refer to next pages

Jerry Zhao, Technical Director Signed for and on behalf of TUV THURINGEN SHANGHAI CO., LTD. Shanghai

Ver.2020.04.17 MASCHERINA PROTETTIVA FFP3 DPI di III categoria Codice articolo MP3-03