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หมวดที่ ถุงมือนิรภัย ESTSAFE R

02 SAFETY GLOVES BESTSAFE GLOVE CO.,LTD

PRODUCT SPECIFICATION BESTSAFE GLOVE CO.,LTD

NITRILE EXAMINATION GLOVES, POWDER FREE
PHYSICAL, FUNCTIONAL AND BIOLOGICAL TESTS

1. INTRODUCTION

Bestsafe Nitrile Powder Free Examination Gloves are worn on the hand of healthcare personnel to prevent contamination
between the healthcare personnel and the patient and to maintain barrier integrity throughout the entire performance of
medical examination activities. Materials used for manufacturing of Bestsafe Nitrile Powder Free Examination Gloves are
qualified and verified to be fit for safe use. The physical and functional properties of Bestsafe Nitrile Powder Free
Examination Glove have been qualified to be suitable and meeting the relevant specifications.
Bestsafe Nitrile Powder Free Examination Gloves are tested according to the following standards :

Standard No. Title
Product specific
EN 455-1:2000 Medical gloves for single use
– Part 1: Requirements and testing for freedom from holes
EN 455-2:2015 Medical gloves for single use
– Part 2: Requirements and testing for physical properties
EN 455-3:2015 Medical gloves for single use
– Part 3: Requirements and testing for biological evaluation
Biocompatibility
ISO 10993-1:2018 Biological evaluation of medical devices
- Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices
- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices
- Part 10: Tests for irritation and skin sensitization
ISO 10993-12:2012 Biological evaluation of medical devices
- Part 12: Sample preparation and reference materials

2.PHYSICAL AND FUNCTIONAL TESTS
Physical and Functional Tests
Physical and functional tests are performed on Bestsafe Nitrile Powder Free Examination Gloves.
These tests include:
• EN 455-1:2000: Requirements for freedom from holes
• EN 455-2:2015: Physical properties test
- Dimension test
- Force at break test
• EN 455-3:2015 (E): Annex A: Proteins extraction by aqueous
Summary of the above mentioned tests performed is tabulated as shown in the test results follows:
• EN 455-4:2015 (E): testing for shelf life determination - on the testing of process with TUV SUD.
Shelf Life :products are warrantee at least 3 years in cool, covered condition , Exterior exposure to
direct sunlight will reduce shelf life and will result in fading, Discoloration and cracking.
Storage : The gloves shall maintain their properties when stored in a dry condition. Avoid direct sunlight

EU MEDICAL DEVICE REGULATION (MDR 2017/745)

EN ISO 374-1:2016+A1:2018 / TYPE B EN ISO 374-5:2016
EN
455
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SECTION 02 ถุงมือนิรภัย บริษัท ปยะมณี กรุป จำกัด BESTSAFE
PIYAMANEE GROUP CO.,LTD
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