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Příloha P_05_certifikat.pdf

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                        Issued to:

Notified Body: 2777 SATRA customer number: P19109

PT Arista Latindo
Jl. K. H. Moh. Mansyur No. 128
Jakarta 11210
Indonesia

 
This EU Type-Examination Certificate covers the following product group(s) supported by testing to the relevant 

standards/technical specifications and examination of the technical file documentation:
Following the EU Type-Examination this product group has been shown to satisfy the applicable essential health and 

safety requirements of Annex II of the PPE Regulation (EU) 2016/425 as a  Category III product.

Standards/Technical specifications applied:
EN ISO 374-1:2016; EN ISO 374-5:2016; EN 420: 2003+A1: 2009

Technical reports/Approval documents:
SATRA: SPC0276516/1841/Reissue, CHM0276481/1841/JG/JS/A/Issue 2, CHM0276481/1841/JG/JS/B/Issue 2, 
CHM0276481/1841/JG/JS/C/Issue 2

Signed on behalf of SATRA:

Page 1 of 2

SATRA Technology Europe Limited. Bracetown Business Park. Clonee. D15YN2P. Republic of Ireland.

Product reference: Description:

Powder Free Nitrile 
Examination Gloves

Powder Free Nitrile Examination Gloves available in blue, white, violet, and green colours. 

Classification:Sizes:
7 S
8 M
9 L
10 XL

EN ISO 374-1: 2016/Type B Level EN 374-4:2013 Degradation
40% Sodium Hydroxide (K) 6 -36.4%
30% Hydrogen Peroxide (P) 2 18.5%
37% Formaldehyde (T) 5 14.1%

EN ISO 374-5: 2016 Result
Protection against bacteria and fungi Pass
Protection against viruses Pass

Certificate number: 2777/13656-02/E00-00

Date first issued: 13/11/2019
Date of issue: 24/01/2020 Expiry date: 13/11/2024



 Page 2 of 2

TERMS AND CONDITIONS

The following conditions apply in addition to SATRA’s standard terms and conditions of business and 
those given in the current certification agreement.

The certificate holder is licensed to mark the products detailed within this certificate in accordance with 
Annex V (Module B) of the Regulation (EU) 2016/425 of the European Parliament and of the council of 
9th March 2016 on personal protective equipment once you have drawn up an EU declaration of product 
conformity. 

Please note:

1. Where the product is classified as category III then CE Marking of production is reliant on 
current compliance with Regulation 2016/425 module C2 or Module D. (Except that specifically 
produced to fit an individual user).

2. Full details of the scope of the certification and product(s) certified are contained within the 
manufacturer’s technical documentation.

3. Where a translation of this certificate exists, the English language version shall be considered 
as the authoritative text.

4. Certification is limited to production undertaken at the sites listed in the manufacturers technical 
documentation.

5. Ongoing manufactured product shall be consistent with the product(s) certified and listed on 
this certificate.

6. The Manufacturer shall inform SATRA of any changes to the certified product or technical 
documentation.

7. Where results obtained during type testing are within the budget of uncertainty when compared 
to the pass requirement, classification or performance level, then it is the responsibility of the 
manufacturer to ensure that the factory production control and manufacturing tolerances are 
such that the product placed on the market meets with the stated requirements, classifications 
or performance levels. 

8. This certificate shall be kept together with the relevant technical documentation in a safe place 
by the client named on this certificate. Production of this certificate and other documentation 
may be required by a representative of the EC member state government.

9. This certificate relates only to the condition of the testable items at the time of the certification 
procedure and is subject to the expiry date shown.

10. SATRA reserves the right to withdraw this certificate if it is found that a condition of 
manufacture, design, materials or packaging have been changed and therefore no 
longer comply with the requirements of Regulation 2016/425.