PPE All Certification

Issued to: Thai Medical Glove Co., Ltd
SATRA customer number: P22048
61/160 Rama 9 Road
Huay Khwang
Huay Khwang
Bangkok
10310
Thailand

Notified Body: 2777

Certificate number: 2777/20681-01/E00-00

This EU Type-Examination Certificate covers the following product group(s) supported by testing to the relevant
standards/technical specifications and examination of the technical file documentation:

Following the EU Type-Examination this product group has been shown to satisfy the applicable essential health and
safety requirements of Annex II of the PPE Regulation (EU) 2016/425 as a Category III product.

Product reference: Description:

TMG-NBR-001 Disposable Powder Free Nitrile Gloves

Colour: Blue

Sizes: Classification: Level EN ISO 374-4:2019 Degradation %
S/6, M/7, L/8, XL/9 6 -2.8
EN ISO 374-1:2016+A1:2018 /Type B 2 43.0
40% Sodium Hydroxide (K) 6 6.8
30% Hydrogen Peroxide (P)
37% Formaldehyde (T)

EN ISO 374-5:2016 Pass
Protection against Bacteria and Fungi Pass
Protection against Viruses

Standards/Technical specifications applied:
EN ISO 21420:2020; EN ISO 374-1:2016+A1:2018; EN ISO 374-5:2016

Technical reports/Approval documents:
SATRA: CHT0321089/2142/Issue 2, CHM0322140/2145/JL/A, CHM0322140/2145/JL/B

Signed on behalf of SATRA: Date first issued: 16/03/2022
Date of issue: 16/03/2022
Expiry date: 16/03/2027

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SATRA Technology Europe Limited. Bracetown Business Park. Clonee. D15YN2P. Republic of Ireland.

TERMS AND CONDITIONS

The following conditions apply in addition to SATRA’s standard terms and conditions of business and
those given in the current certification agreement. This certificate has been issued in accordance with
Annex V (Module B) of the applicable legislation (see note 11).

Please note:

1. Where the product is classified as category III then CE or UKCA Marking of production is reliant
on current compliance with module C2 or Module D of the applicable legislation (See note 11).
(Except that specifically produced to fit an individual user).

2. Full details of the scope of the certification and product(s) certified are contained within the
manufacturer’s technical documentation.

3. Where a translation of this certificate exists, the English language version shall be considered
as the authoritative text.

4. Certification is limited to production undertaken at the sites listed in the manufacturer’s
technical documentation.

5. Ongoing manufactured product shall be consistent with the product(s) certified and listed on
this certificate and an EU declaration of product conformity shall be made available in
accordance with the applicable legislation (See note 11)

6. The Manufacturer shall inform SATRA of any changes to the certified product or technical
documentation.

7. Where results obtained during type testing are within the budget of uncertainty when compared
to the pass requirement, classification or performance level, then it is the responsibility of the
manufacturer to ensure that the factory production control and manufacturing tolerances are
such that the product placed on the market meets with the stated requirements, classifications
or performance levels.

8. This certificate shall be kept together with the relevant technical documentation in a safe place
by the client named on this certificate. Production of this certificate and other documentation
may be required by a representative of the EC member state, or UK government.

9. This certificate relates only to the condition of the testable items at the time of the certification
procedure and is subject to the expiry date shown.

10. SATRA reserves the right to withdraw this certificate if it is found that a condition of
manufacture, design, materials or packaging have been changed and therefore no
longer comply with the requirements of the applicable legislation (See note 11).

11. These terms and conditions shall apply to the requirements set out in Regulation (EU)
2016/425 of the European Parliament and of the council of 9th March 2016 on personal
protective equipment or to UK legislation relating to UKCA Marking as defined within the
issued certificate.

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Test Report No. 7191257368-EEC21-WBH

dated 10 May 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

CLIENT
Thai Medical Glove Co., Ltd.
363/2 Moo 8, Tambol Bangphra, Sriracha
Chonburi THAILAND 20110
Attn: K. Panita Buathong

SAMPLE SUBMISSION DATE/ TEST DATE
29 Mar 2021/ 09 Apr 2021 to 06 May 2021

DESCRIPTION OF SAMPLES

S/N Product Brand/ Size Colour Lot No. Expiry Sample
Description Model Date Received Manufacturer
(pieces)

1 TMG L Blue TMG01022021b.1 14.02.2026 400

Nitrile L Blue TMG01022021b.2 19.02.2026 400 Thai Medical
2 Examination TMG Glove Co., Ltd.

Gloves

3 TMG L Blue TMG01022021b.3 24.02.2026 400

Lot size as specified by client: 35,001 to 150,000 pieces

METHOD OF TEST

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- Clauses 6.1.2 & 7.3 Freedom from Holes (Cross-reference to Test Method D5151)
- Clauses 6.1.3 & 7.4 Physical Dimensions Test
- Clauses 6.1.4 & 7.5 Physical Requirements Test – Die C, accelerated aging conducted according to

Clause 7.5.2.1: temperature of 70±2°C for 166±2h (Cross-reference to Test Method D412 and D573)
- Clauses 6.1.5 & 7.6 Powder-free Residue (Cross-reference to Test Method D6124)

Laboratory: Phone : +65-6778 7777 Regional Head Office:
TÜV SÜD PSB Pte. Ltd. E-mail: [email protected] TÜV SÜD Asia Pacific Pte. Ltd.
15 International Business Park https://www.tuvsud.com/sg 15 International Business Park
TÜV SÜD @ IBP Co. Reg : 199002667R TÜV SÜD @ IBP
Singapore 609937 Singapore 609937
Page 1 of 5

Test Report No. 7191257368-EEC21-WBH

dated 10 May 2021

RESULTS

Sample: Nitrile Examination Gloves, TMG, Blue, Size L

Table 1: Results for Freedom from Holes

Clause Tests Requirements Lot No. No. of Number Actual no. Inferred
non- tested of non- results
TMG0102 compliers (pieces)
2021b.1 allowed compliers Passed
(pieces) 200 found Passed
Passed
10 200 (pieces)

6.1.2 Freedom Shall not leak TMG0102 10 200 4
7.3 from holes 2021b.2
5
TMG0102 10
2021b.3 2

Table 2: Results for Physical Dimensions Test

Require- Results (mm) Number of pieces
ments Min. Mean Max.
Clause Tests (mm) Lot No. Non- Actual non- Inferred
103 105 107 results
For size L: TMG010 compliers Tested compliers
110 ± 10 22021b.1
TMG010 allowed found
For size L: 22021b.2
a) Width 230 TMG010 103 105 107
22021b.3
0.05 TMG010 104 105 107
22021b.1
0.05 TMG010 238 240 243
22021b.2
b) Length TMG010 239 240 243
22021b.3
6.1.3 TMG010 237 241 243 1 13 0 Passed
7.4 22021b.1 0.13 0.14 0.14 per lot per for all for all
TMG010 lot the lots the lots
c) Finger 22021b.2
thickness TMG010 0.13 0.14 0.14
22021b.3
d) Palm TMG010 0.13 0.14 0.14
thickness 22021b.1
TMG010 0.09 0.09 0.09
22021b.2
TMG010 0.09 0.09 0.10
22021b.3
0.09 0.09 0.09

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Test Report No. 7191257368-EEC21-WBH

dated 10 May 2021

RESULTS (cont’d):

Sample: Nitrile Examination Gloves, TMG, Blue, Size L

Table 3: Results for Physical Requirements Test – before accelerated aging

Require- Results Number of pieces
ments Mean Max.
Clause Tests 14 Lot No. Non- Actual non- Inferred
29 38 results
500 TMG010 Min. compliers Tested compliers
22021b.1 18
TMG010 allowed found
22021b.2
Tensile TMG010 20 29 39
strength 22021b.3
(MPa) TMG010
22021b.1
6.1.4 TMG010 18 27 35 1 13 0 Passed
7.5 22021b.2 544 586 624 per lot per for all for all
TMG010 lot the lots the lots
22021b.3
Ultimate 512 551 592
elongation
(%)

508 548 580

Table 4: Results for Physical Requirements Test – after accelerated aging

Require- Results Number of pieces
ments Mean Max.
Clause Tests Lot No. Non- Actual non- Inferred
14 34 43 results
TMG010 Min. compliers Tested compliers
400 22021b.1 20
TMG010 allowed found
22021b.2
Tensile TMG010 22 32 44
strength 22021b.3
(MPa) TMG010
22021b.1
6.1.4 TMG010 16 24 31 1 13 0 Passed
7.5 22021b.2 520 566 584 per lot per for all for all
TMG010 lot the lots the lots
22021b.3
Ultimate 512 545 572
elongation
(%)

516 571 612

Table 5: Results for Powder-Free Gloves

Clause Tests Requirements Lot No. Result Inferred Results
Passed
6.1.5 Powder-free Powder residue TMG01022021b.1 0.34 mg per glove
TMG01022021b.2 0.42 mg per glove
7.6 gloves 2.0 mg TMG01022021b.3 0.42 mg per glove

Yeo Poh Kwang Wong Bee Hui
Associate Engineer Product Manager
Medical Health Services (NAM)

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Test Report No. 7191257368-EEC21-WBH

dated 10 May 2021
APPENDIX:

Photo: Nitrile Examination Gloves, TMG, Blue, Size L

Page 4 of 5

Test Report No. 7191257368-EEC21-WBH

dated 10 May 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.
4. This report shall not be reproduced wholly or in parts and no reference shall be made by the Client to TÜV SÜD PSB or to the report or results
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 TÜV SÜD @ IBP 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 26 January 2021

Page 5 of 5

USER INFORMATION

These products are classed as Category III Personal Protective Equipment (PPE) by the European PPE
REGULATION 2016/425 and have been shown to comply with this Regulation through the Harmonised
European Standard(s): EN ISO 21420:2020, EN ISO 374-1:2016+A1:2018, EN ISO 374-5:2016

Product reference: TMG-NBR-001
Sizes available S(6), M(7), L(8), XL(9)

Intended Use: For the covering of hands of medical staff during examination procedure involving patient
body surfaces and patient body orifices.

Performance and limitation of use –This product has been tested and achieved the following performance
levels:

Classification:

EN ISO 374-1:2016+A1:2018 Level EN ISO 374-4:2019 EN ISO 374-1:2016+A1:2018 /Type B
/Type B 6 Degradation%

40% Sodium Hydroxide (K) -2.8

30% Hydrogen Peroxide (P) 2 43.0 KPT
37% Formaldehyde (T) 6 6.8

EN ISO 374-5:2016 Pass EN ISO 374-5:2016
Protection against Bacteria Pass
and Fungi Virus
Protection against Viruses

EN ISO 374-1:2016+A1:2018 Permeation levels are based on breakthrough times as follows:

Permeation performance level 1 23 4 5 6
＞480
Measured breakthrough time (min) ＞10 ＞30 ＞60 ＞120 ＞240

EN ISO 374-4:2019 Degradation results indicate the change in puncture resistance of the gloves after exposure to
the challenge chemical:

EN ISO 374-5:2016 The penetration resistance has been assessed under laboratory conditions and relates only to
the tested specimen.”

“This information does not reflect the actual duration of protection in the workplace and the
differentiation between mixtures and pure chemicals”

“The chemical resistance has been assessed under laboratory conditions from samples taken from the
palm only (except in cases where the glove is equal to or over 400 mm - where the cuff is tested also) and
relates only to the chemical tested. It can be different if the chemical is used in a mixture.”

“It is recommended to check that the gloves are suitable for the intended use because the conditions at
the workplace may differ from the type test depending on temperature, abrasion and degradation.”

“When used, protective gloves may provide less resistance to the dangerous chemical due to changes in
physical properties. Movements, snagging, rubbing, degradation caused by the chemical contact etc. may
reduce the actual use time significantly. For corrosive chemicals, degradation can be the most important
factor to consider in selection of chemical resistant gloves”

“Before usage, inspect the gloves for any defect or imperfections.”

Storage and transport: When not in use, store the product in a well-ventilated area away from extremes of
temperature

Glove performance quoted is based on laboratory data and may not reflect the actual duration of protection in
the workplace due to other factors influencing the performance such as temperature, abrasion, degradation etc.)

The glove does not contain any substances that are known to cause allergies.
The Gloves have no mechanical protection offered.
For single use only, do not littering.
Check for damage before use, do not use damaged gloves

Donning:
1. Remove all hand and wrist jewelry, and wash the hands before donning.
2. Place the gloves on the prepared work surface.
3. The user puts a glove on his/her dominant hand by grabbing it with the other hand, remembering to
only touch the inside of the gloves, and slipping it over the dominant hand until it reaches final level.
4. The wearer uses the gloved dominant hand to slip the other glove onto the non-dominant hand.
5. Once both gloves are on, the users can touch the outside of the gloves to ensure a proper fit

Doffing:
1. Using the dominant hand, users start by grabbing the outside of the glove on the non-dominant hand
on the palm side near the cuff.
2. Pull the glove off the non-dominant hand and place it in the gloved hand, balling it up.
3. Slip two fingers under the cuff of the other hand glove and carefully peel it off the hand without
touching the wrist, turning the remaining glove inside put as it is removed and in turn encasing the first
glove.
4. The gloves can be disposed.

The DoC (declaration of conformity) will be shown on website: https://thaimedicalglove.co.th/en/business-overview/
Notified Body responsible for certification and ongoing conformity:
SATRA Technology Europe Ltd
Bracetown Business Park
Clonee, Dublin
D15 YN2P, Ireland (2777)

Product manufactured by: THAI MEDICAL GLOVE CO., LTD
61/160 Rama 9 Road, Huay Khwang, Huay Khwang, Bangkok THAILAND 10310.