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หมวดที่ ถุงมือนิรภัย ESTSAFE ®

02 SAFETY GLOVES BESTSAFE GLOVE CO.,LTD

GLOVE SIZING & LENGHT CHART BESTSAFE GLOVE CO.,LTD

PROTEINS EXTRACTION

POWDER FREE | IRRITANTS

Gloves are manufactured with a wide variety of chemicals, with free powders and irritants

that may cause you harm. Properties are exists to ensure that you are protected from the glove.

Test Parameter Unit MDL Results Abbreviation : ug/g = microgram per gram

MDL = method detection limit
Protiens ug/g 3 n.d n.d. = Not detected (<MDL)

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.

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SECTION 02 ถุงมือนิรภัย บริษัท ปยะมณี กรุป จำกัด BESTSAFE
PIYAMANEE GROUP CO.,LTD
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