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Certificate
Standard ISO 9001:2015
Ce
te Registr. No. 01 100 1835570
ea Apex Glove Sdn. Bhd.
No. 24 A, Jalan Tiara 2, Tiara Square, Taman Perindustrian UEP,
47600 Subang Jaya, Selangor, Malaysia
‘Scope: Provision of Sourcing & Supply of Glove (Latex, Nitrile)
Proof has been furnished by means of an audit that the
requirements of ISO 9001:2015 are met.
Validity The certificate is valid from 2018-12-06 until 2021-12-05.
2018-12-11 \ :
wwwtuv.com ED (m5, ZS tovrheiniand?
ssrtearars Precisely Right. EU Declaration of Conformity
According to Medical Device Regulation (EU) 2017/745
For the following Equipment
Product _ Disposable Latex Examination Gloves (Non-Sterile) Class T
Powdered & Powder Free Type
ECRINo, = 11882 (base on ECRI Universal Medical Device Nomenclature System)
ied above meet the requirement of the
“ass 1 Medical device set out in Rule
ompliance with the Regulation, the
We hereby declare that the medical device specifi
Medical Device Regulation (EU) 2017/745, under Cl
number 5 of Annex VIII.For the evaluation of the
following standards were applied:
Edition/date
Standard Title
EN 455-1 Medical Gloves for single use: Requirements and testing for 2020
freedom from holes
EN455-2 Medical Gloves for single use: Requirements and testing for 2015
physical properties
EN455.3 Medical Gloves for single use: Requirements and testing for 2015
biological evaluation
EN4SS-4 Medical Gloves for single use: Requirements and testing for 2009
shelf life determination
1999
1S0 2859-1 Sampling procedures for inspection by attributes — Part 1:
‘sampling plans indexed by acceptable quality level (AQL)
for lot by lot inspection
‘Standard Specification for Rubber Examination Gloves for 2019
ASTM D-3578
Medical Application
Responsible for making this declaration is the:
(x) Manufacturer (.) Authorized representative established within the EU
“Authorized representative established within the EU (if applicable):
Company name
‘Address -
Single Registration Number :
Person responsible for making this declaration
Name Brie Ngan
Position : Export Manager
Manufacturer's Name APEX GLOVE SDN BHD
No 5, Lorong Astana 1A/KU2, Bandar Bukit Raja,
41050 Klang, Selangor, Malaysia
(T) +603 3082 9393 ~ (F) + 603 3082 9292
‘August 11, 2021
