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หมวดที่ ถุงมือนิรภัย ESTSAFE R

02 SAFETY GLOVES BESTSAFE GLOVE CO.,LTD

BESTSAFE GLOVE CO.,LTD
SPECIFICATION SHEET OF GLOVE
PRODUCT SPECIFICATION BESTSAFE GLOVE CO.,LTD
NITRILE EXAMINATION GLOVES, POWDER FREE
PHYSICAL, FUNCTIONAL AND BIOLOGICAL TESTS

3.BIOLOGICAL TESTS

Bestsafe Nitrile Powder Free Examination Glove is a single use device that contacts intact skin surfaces.
It is categorized according to its intended use, body contact and duration, according to ISO 10993-1:2018.

Product description Bestsafe Nitrile Powder Free Examination Glove
Nature of body contact Surface medical device, intact skin
Duration of contact A – Limited (< 24 hrs)
Biological Endpoints to be considered •In Vitro Cytotoxicity
•Skin irritation (inner & outer)
•Skin sensitization
Test Laboratory GLR Laboratories Private Limited
Justification for choosing Test Laboratory Test Laboratory is GLP and IEC/ISO 17025 accredited.

CHEMICAL TOXICOLOGY ASSESSMENT
Chemical toxicology assessment was not performed since materials used are well characterized
and with a long history of safe use. There was no change in material and processes in producing
Bestsafe Nitrile Powder Free Examination Glove that would introduce new hazard to the user.

RISK ASSESSMENT
Materials used in the product have been well characterized based on long history of safe use.
The risk associated with use of the product should be minimal since materials have been well
characterized and there is no change in intended use, body contact and duration of contact.

BIOLOGICAL RESULT OF TESTS
Item Biocompatibility Tests ISO 10993 Standards Study No. Result (Acc/Rej)
1 In Vitro Cytotoxicity Study ISO 10993-5:2009 667/001 Accept
2 Skin irritation study (inner surface) ISO 10993-10:2010 667/002 Accept
3 Skin irritation study (outer surface) ISO 10993-10:2010 667/003 Accept
4 Skin sensitization study (maximization method) ISO 10993-10:2010 667/004 Accept

Biological tests of Bestsafe Nitrile Powder Free Examination Gloves did not show any abnormality
and met the respective requirements of the endpoints of biological tests. This shows that
Bestsafe Nitrile Powder Free Examination Gloves meet biological requirements and product is
deemed safe for use.

All Biological tests on Bestsafe Nitrile Powder Free Examination Gloves showed no abnormality
and met the requirements of respective ISO 10993 standards. Thus, it is not expected to cause any
undesirable side effect when used as intended.

Bestsafe Nitrile Powder Free Examination Glove is qualified to meet Biological requirements as
per ISO 10993-1:2018. This product is safe to be used as indicated.
EU MEDICAL DEVICE REGULATION (MDR 2017/745)
EN ISO 374-1:2016+A1:2018 / TYPE B EN ISO 374-5:2016
EN
455
KPT VIRUS
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บริษัท ปยะมณี กรุป จำกัด BESTSAFE ถุงมือนิรภัย SECTION 02
PIYAMANEE GROUP CO.,LTD BEST SAFE (THAILAND) CO.,LTD SAFETY GLOVES
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