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DECLARATION OF CONFORMITY

MEDICAL GLOVE CO., LTD.

DECLARATION OF CONFORMITY

EU DECLARATION OF CONFORMITY

1)

Company Name:
Medical Glove Co., Ltd
Address:
288 Moo 7 T.Lam Thap, A. Lam Thap, Krabi 81190 Thailand
Product code:
NBR-001

2) This declaration of conformity is issued under the sole responsibility of the manufacturer:

Company Name:
Medical Glove Co., Ltd
Address:
288 Moo 7 T.Lam Thap, A. Lam Thap, Krabi 81190 Thailand

3) insert description of the object of declaration (identification of PPE allowing traceability; where necessary for the identification of the PPE a colour image of sufficient clarity maybe included)

Product declaration for size S, M, L, XL

4)The object of the declaration descried in point 4 is in conformity with the relevant

Union harmonisation legislation: Regulation (EU) 2016/425

5) References to the relevant harmonised standards used, including the date of the standard or references to the other technical specification, including the date of the specification, in relation to which conformity is declared:

Standards/ Technical Specifications applied
EN ISO 21420: 2020 : General requirements and test methods
EN ISO 374-1:2016+A1:2018: Terminology and performance requirements for chemical risks
EN 374-2: 2019: Determination of resistance to penetration
EN 374-4:2019: Determination of resistance to degradation by chemicals
EN 374-5:2016: Terminology and performance requirements for micro-organisms risks
EN 16523-1: 2015+A1: 2018: Permeation by potentially hazardous liquid chemicals under conditions of continuous contact

6) Where applicable, the notified body SATRA Technology Europe 2777 performed the EU examination (Module B) and issued the EU type- examination certificate (Reference to that certificate)

7) Where applicable, the PPE is subject to the conformity assessment procedure (either conformity to type based on internal production control plus supervised product checks at random intervals (module C2) under surveillance of the notified body: SATRA Technology Europe Ltd, Bracetown Business Park, Clonee, Dublin 15D15 YN2PIreland Tel:+00353 (0) 1 437 2484; Notified Body Number: 2777)

8) Additional information

Signed for and on behalf of
Medical Glove Co., Ltd
Date of issue
4 August 2020
Name, function

Wandee Rattanajamnong (Ms)
RA/QA Manager

It is optional for the manufacturer to assign a number to the declaration of conformity.

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Address:: 288 Moo 7. Tambon Lam Thap, Amphur Lam Thap, Krabi 81190
Phone: (+66) 097 359 9867
Email: inquiry@medicalglove.net
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