Test Report No.
7191250395-EEC21-WBH
dated 07 Jan 2021
Note: This report is issued subject to the Testing and Certification Regulations of the TÜV SÜD Group and the
General Terms and Conditions of Business of TÜV SÜD PSB Pte Ltd. In addition, this report is governed by the
terms set out within this report.
SUBJECT:
Testing of Gloves submitted by Guangdong Kingfa Sci.& Tech. Co., Ltd.
on 10 Dec 2020.
TESTED FOR:
Guangdong Kingfa Sci.& Tech. Co., Ltd.
No. 28 Delong Avenue, Shijiao Town,
Qingcheng District,
Qingyuan City, Guangdong Province,
China
TEST DATE:
11 Dec 2020 to 02 Jan 2021
DESCRIPTION OF SAMPLES:
Sample
Product
S/N Brand/ Model Size Colour Lot No. Expiry Date Received Manufacturer
Description
(pieces)
Nitrile Guangdong Kingfa
1 Examination KS-ST RT021 M Blue 25007031 2023-07-15 444 Sci.& Tech. Co.,
Glove Ltd.
Lot size as specified by client: 35,001 to 150,000 pieces
METHOD OF TEST:
1. EN 455-1:2020 Medical gloves for single use
Part 1: Requirements and testing for freedom from holes
2. EN 455-2:2015 Medical gloves for single use
Part 2: Requirements and testing for physical properties
3. EN 455-3:2015 Medical glove for single use
Part 3: Requirements and testing for biological evaluation
Laboratory: Phone : +65-6778 7777 Regional Head Office:
TÜV SÜD PSB Pte. Ltd. E-mail: [Link]@[Link] TÜV SÜD Asia Pacific Pte. Ltd.
[Link] TÜV SÜD @ IBP
TÜV SÜD @ IBP
Co. Reg : 199002667R 15 International Business Park
15 International Business Park
Singapore 609937
Singapore 609937 Page 1 of 5
Test Report No. 7191250395-EEC21-WBH
dated 07 Jan 2021
RESULTS:
Sample: Nitrile Examination Glove, KS-ST RT021, Blue, Size M
Table 1: Results for EN 455-1:2020
No. of Number Actual no. of
Inferred
Clause Tests Requirements non-compliers tested non-compliers
results
allowed (pieces) (pieces) found (pieces)
4 Freedom
Shall not leak 7 200 2 Passed
5 from holes
Table 2: Results for EN 455-2:2015 Clauses 4-5
Requirements Number tested Results Inferred
Clause Tests
(Median) (pieces) (Median) results
Dimensions
240 13 252 Passed
a) Length (mm)
4
For Size M:
b) Width (mm) 13 96 Passed
95 ± 10
For nitrile
Strength
examination
a) Force at break 13 10.6 Passed
gloves:
(N)
6.0
5 b) Force at break
For nitrile
after challenge
examination
testing (N) 13 9.3 Passed
gloves:
7 days at
6.0
(70±2)oC
Table 3: Results for EN 455-2:2015 Clause 7
Inferred
Clause Tests Requirements Results
results
Manufacturers shall label the glove and/or
the packaging with the date of manufacture
in accordance with EN ISO 15223-1:2012
7 Labelling Comply Passed
and EN 1041:2008+A1:2013. Date of
manufacture is defined as the packaging
date.
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Test Report No. 7191250395-EEC21-WBH
dated 07 Jan 2021
RESULTS (cont’d):
Sample: Nitrile Examination Glove, KS-ST RT021, Blue, Size M
Table 4: Results for EN 455-3:2015 Clauses 4.2-4.5
Inferred
Clause Tests Requirements Results / Remarks
results
Glove is talcum powder-free
Gloves shall not be dressed with talcum
glove, based on client’s Passed
powder (magnesium silicate).
declaration letter
4.2 Chemicals
Manufacturer shall disclose
Other chemicals upon request a list of NA
chemical ingredients
4.3 < 20 EU/pair for gloves labelled with Not labelled with ‘low
Endotoxins NA
5.1 ‘low endotoxin content’. endotoxin content’
For powder-free gloves: The total
4.4 Powder-
quantity of powder residues shall not 0.18 mg per glove Passed
5.2 free gloves
exceed 2 mg per glove.
The manufacturer shall strive to
4.5 Proteins, Not natural rubber latex
minimize the leachable protein level for NA
5.3 leachable glove
gloves containing natural rubber latex.
Table 5: Results for EN 455-3:2015 Clause 4.6
Clause Tests Requirements Results
In addition to the labelling specified in EN 1041:2008+A1:2013 and the
relevant symbols given in EN ISO 15223-1:2012, the following
requirements apply:
a) medical gloves containing natural rubber latex shall be labelled on
the packaging of at least the smallest packaging unit with the EN NA
ISO 15223-1:2012 symbol for latex;
The labelling shall include the following or equivalent warning
statement together with the symbol: ‘(Product) contains natural
NA
rubber latex which may cause allergic reactions, including
anaphylactic responses’;
b) the labelling shall include a prominent indication of whether the
Comply
4.6 Labelling glove is powdered or powder-free;
c) sterile powdered gloves shall be labelled with the following or
equivalent: ‘CAUTION: Surface powder shall be removed
NA
aseptically prior to undertaking operative procedures in order to
minimize the risk of adverse tissue reactions’;
d) for any medical glove containing natural rubber latex the product
labelling shall not include:
- any term suggesting relative safety, such as low allergenicity, NA
hypoallergenicity or low protein;
- any unjustified indication of the presence of allergens;
e) if the manufacturer labels the gloves with the protein content, the
NA
process limit, measured as specified in 5.3 shall be given.
Inferred results Passed
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Test Report No. 7191250395-EEC21-WBH
dated 07 Jan 2021
REMARKS:
1. Labelling requirements are assessed based on the submitted packaging artwork by client.
2. NA: Not applicable for the submitted sample.
Yeo Poh Kwang Wong Bee Hui
Associate Engineer Product Manager
Medical Health Services (NAM)
APPENDIX:
Photo 1: Nitrile Examination Glove, KS-ST RT021, Blue, Size M
Photo 2: Packaging artwork for Nitrile Examination Glove, KS-ST RT021, Blue, Size M
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Test Report No. 7191250395-EEC21-WBH
dated 07 Jan 2021
Please note that this Report is issued under the following terms :
1. This report applies to the sample of the specific product/equipment given at the time of its testing/calibration. The results are not used to
indicate or imply that they are applicable to other similar items. In addition, such results must not be used to indicate or imply that TÜV SÜD
PSB approves, recommends or endorses the manufacturer, supplier or user of such product/equipment, or that TÜV SÜD PSB in any way
“guarantees” the later performance of the product/equipment. Unless otherwise stated in this report, no tests were conducted to determine
long term effects of using the specific product/equipment.
2. The sample/s mentioned in this report is/are submitted/supplied/manufactured by the Client. TÜV SÜD PSB therefore assumes no
responsibility for the accuracy of information on the brand name, model number, origin of manufacture, consignment or any information
supplied.
3. Nothing in this report shall be interpreted to mean that TÜV SÜD PSB has verified or ascertained any endorsement or marks from any other
testing authority or bodies that may be found on that sample.
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furnished by TÜV SÜD PSB in any advertisements or sales promotion.
5. Unless otherwise stated, the tests were carried out in TÜV SÜD PSB Pte Ltd, 15 International Business Park Singapore 609937.
6. The tests carried out by TÜV SÜD PSB and this report are subject to TÜV SÜD PSB’s General Terms and Conditions of Business and the
Testing and Certification Regulations of the TÜV SÜD Group.
Effective 01 January 2021
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