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