Intco Satra

Issued to: Anhui Intco Medical Products Co.
, Ltd
Haitang Road West and Yinhua Road North
Suixi Wuhu Modern Industrial Park
Suixi Town
Huaibei City
Anhui Province
China
Notified Body: 2777 SATRA customer number: P20118
Certificate number: 2777/14815-02/E00-00

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.
Product reference: Description:
Blue NGPF7000-7005 Disposable Nitrile Gloves (Non-sterile).
Black BNPF7000-7005
White WNPF7000-7005
Violet NGPF7000-V1-7005-
V1
Sizes: Classification:
6-11(XS-XXL) EN ISO 374-1:2016+A1:2018/Type B Level EN ISO 374-4:2019 Degradation %
40% Sodium hydroxide (K) 6 -68.1
30% Hydrogen peroxide (P) 2 30.5
37% Formaldehyde (T) 5 9.5
EN ISO 374-5:2016 Level

Protection against Bacteria and Fungi Pass
Protection against Viruses Pass
Standards/Technical specifications applied:

EN ISO 21420:2020; EN ISO 374-1:2016+A1:2018; EN ISO 374-5:2016
Technical reports/Approval documents:

SATRA: CHT0296241/2012, CHM0298100/2020/EN/A, CHM0298100/2020/EN/B
SGS: CH:TX:1142011147, CH:TX:1142011145-1, CH:TX:1142011148
TUV: 7191234075-CHM20-02-TSL, 7191235025-EEC20-WBH_CR1, 721652920
Signed on behalf of SATRA:

Date first issued: 20/07/2020
Date of issue: 26/07/2020 Expiry date: 20/07/2025
Page 1 of 2
SATRA Technology Europe Limited. Bracetown Business Park. Clonee. D15YN2P. Republic of Ireland.
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.
Page 2 of 2

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Issued to: Anhui Intco Medical Products Co.

Notified Body: 2777 SATRA customer number: P20118

Certificate number: 2777/14815-02/E00-00

EN ISO 374-5:2016 Level

Standards/Technical specifications applied:

Technical reports/Approval documents:

Signed on behalf of SATRA:

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