FDA ASTM-510K All Certification

Page 1 of 7

K213500

510(k) SUMMARY
Nitrile Powder Free Examination Gloves

1.0 Appliance Information THAI MEDICAL GLOVE CO., LTD
363/2 Moo 8, Tambol Bangphra, Sriracha, Chonburi.
Applicant: THAILAND 20110
Address: +6638-198-102

Phone Number: N/A
Fax Number:
Email: [email protected]
Name of Contact Person:
Designation: Noppadol Polbundit (Mr)
Contact Number:
Contact Email: Operation Director
Date 510(k) summary prepared:
66 96 445 3256

[email protected]
February 07, 2022

2.0 Identification of the subject device

Trade/Proprietary Name(s): TMG NITRILE POWDER FREE EXAMINATION GLOVE
Common Name: Nitrile Powder Free Examination Gloves
Classification Name: Patient Examination Gloves
Device Class: I
product code LZA
Regulation Number: 21 CFR 880.6250
Review Panel: General Hospital

3.0 Predicate Device Palm Care Blue Nitrile Examination Gloves Powder Free
Device Name: K202384
510(k): Patient Examination Gloves
Common Name: Patient Examination Gloves
Classification Name: I
Device Classification LZA
Product Code: 21 CFR 880.6250
Regulation Number:

THAI MEDICAL GLOVE CO., LTD. (BANG PHRA FACTORY) www.thaimedicalglove.co.th
[email protected]
363/2 Moo 8, Tambol Bangphra, Sriracha, Chonburi, THAILAND 20110

Page 2 of 7

4.0 Description of the Device

TMG Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the
product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene
copolymer dispersion. These gloves are blue in color and are powder free.

5.0 Indication for Use of the Device

TMG nitrile powder free examination glove is a disposable device intended for medical purpose that
is worn on the examiner's hand to prevent contamination between patient and examiner.

6.0 Summary of Technological Characteristics of the Device Compared to the Predicate Device

Device performance

Characteristics Standards Comparison

Predicate Current

510(k) Number - K202384 K213500 ----

Manufacturer(s) - Hi-Care Thai Gloves Co. Ltd THAI MEDICAL GLOVE ----
CO., LTD.

Name of device - Blue Nitrile Blue Nitrile ----
Indication for Use Examination Gloves Examination Gloves Similar
Medical Gloves Powder free Powder free
Guidance Manual -
Issued on January Blue Nitrile TMG nitrile powder free
22, 2008 examination glove is a
Examination Gloves disposable device intended
for medical purpose that is
Powder-free is disposable worn on the examiner's hand
to prevent contamination
devices intended for medical between patient and
examiner.
purpose that are won on the

examiner’s hand to prevent

contamination between

patient and examiner

Material ASTM D6319-19 Nitrile (NBR) Nitrile (NBR) Same

Color - Blue Blue Same

Texture - Textured Fingers Textured Fingers Same
Size ASTM D6319-19 Different
Extra Small Small
Small Medium
Medium Large
Large Extra Large
Extra Large

THAI MEDICAL GLOVE CO., LTD. (BANG PHRA FACTORY) www.thaimedicalglove.co.th
[email protected]
363/2 Moo 8, Tambol Bangphra, Sriracha, Chonburi, THAILAND 20110

Page 3 of 7

Device performance

Characteristics Standards Predicate Current Comparison
Single Use Medical Gloves Same
Dimension Guidance Manual - Single use Single use Same
Thickness Issued on January Same
22, 2008 Meet ASTM D6319-19 Meet ASTM D6319-19 Same
-Labeling
Length 230 mm min. Length 230 mm min. Similar
ASTM D6319-19 Similar
Width 95 ± 10 mm min Width 95 ± 10 mm min
ASTM D6319-19 (for Medium size) (for Medium size)

Meet ASTM D6319-19 Meet ASTM D6319-19
Finger: 0.05 mm min
Finger: 0.05 mm min Palm: 0.05 mm min
Palm: 0.05 mm min

Physical ASTM D6319-19 Meet ASTM D6319-19 Meet ASTM D6319-19
Properties ASTM D5151-19
Before aging Before aging
Watertight test Tensile Strength:
(1000 ml) Tensile Strength:
Powder Residue 14 MPa min 14 MPa min
Ultimate Elongation: Ultimate Elongation:
500% min 500% min
After aging
After aging Tensile Strength
14 MPa min
Tensile Strength Ultimate Elongation:
14 MPa min 400% min
Ultimate Elongation:
400% min Pass AQL 1.5

Pass AQL 1.5 Meet
< 2.0 mg/glove
ASTM D6124-06 Meet

(Reapproved 2017) < 2.0 mg/glove

THAI MEDICAL GLOVE CO., LTD. (BANG PHRA FACTORY) www.thaimedicalglove.co.th
[email protected]
363/2 Moo 8, Tambol Bangphra, Sriracha, Chonburi, THAILAND 20110

Page 4 of 7

Device performance

Characteristics Standards Comparison
Same
Predicate Current

Biocompatibility Primary Skin Under the conditions Under the conditions
Irritation – of the study, not an of the study, not an
ISO 10993-10 Third irritant irritant
Edition 2010-08-01

Dermal Under the conditions Under the conditions Same
Sensitization – of the study, not a of the study, not a
ISO 10993-10 Third sensitizer sensitizer

Edition 2010-08-01

In vitro cytotoxicity Under the conditions Under the conditions of the Different
ISO10993-5 of the study, noncytotoxic study cytotoxic for undiluted, Same
:2009(E) 1:2 and 1:4 dilutions but
Under the conditions of noncytotoxic for 1:8, 1:16
Acute Systemic study, the device extracts do and 1:32 dilutions. Moreover,
Toxicity ISO10993- not pose a systemic toxicity under the conditions of the
11:2017(E) concern study, non acute systemic
toxic.

Under the conditions of the
study, did not induce any
systemic toxicity.

There are no significant differences between the two products and are identical in terms of intended use,

materials, design, manufacturing methods. Both devices meet the ASTM standards.

THAI MEDICAL GLOVE CO., LTD. (BANG PHRA FACTORY) www.thaimedicalglove.co.th
[email protected]
363/2 Moo 8, Tambol Bangphra, Sriracha, Chonburi, THAILAND 20110

7.0 Non-clinical testing summary

Performance Data Purpose of testing Acce

Test Method Standard To determine the length Min 2
of the gloves
ASTM D6319-19
Standard Specification for Nitrile
Examination Gloves for Medical
Application

Dimension ASTM D6319-19 To determine the width Smal
Standard Specification for Nitrile of the gloves Medi
Examination Gloves for Medical Large
Application To determine the Extra
thickness of the gloves
ASTM D6319-19 Palm
Standard Specification for Nitrile Finge
Examination Gloves for Medical
Application

Watertight test ASTM D5151-19 To determine the holes in Samp
Standard Test Method for Detection the gloves Inspe
of Holes in Medical AQL
Gloves Acce
Rejec

THAI MEDICAL GLOVE CO., LTD. (BANG PHRA FACTORY)

363/2 Moo 8, Tambol Bangphra, Sriracha, Chonburi, THAILAND 20110

Attachment 17
Page 5 of 7

eptance Criteria Result Status

230 mm for all sizes Small: 243 mm Pass
Medium: 240 mm Pass
ll: 80 + 10 mm Large: 240 mm Pass
ium: 95 ± 10 mm Extra Large: 240 mm
e: 110± 10 mm Pass
a Large: 120 ± 10 mm Small: 85 mm
Medium: 93 mm
m 0.05 mm min Large: 105 mm
er 0.05 mm min for all sizes Extra Large: 115 mm

ple size: 200 pcs Small: Palm 0.09 mm, Finger: 0.13 mm
ection level : GI Medium: Palm: 0.06 mm, Finger: 0.08 mm
1.5 Large: Palm 0.09 mm, Finger: 0.12 mm
eptance Number 7 Extra Large: Palm 0.09 mm, Finger: 0.12
ction Number 8 mm

The batch size for this sampling is 35,001-
150,000. Hence, according to the single
sampling plan GI, the sample to be drawn
is under code L equivalent to 200 pcs with
accept 7 and reject 8 to be accept under
AQL 1.5...

Small: 0 (Zero)
Medium: 0 (Zero)
Large:0 (Zero)
Extra Large:0 (Zero).

www.thaimedicalglove.co.th
[email protected]

Test Method Standard Purpose of testing Acce

Residual ASTM D6124-06 (Reapproved 2017) To determine the residual 2 mg
powder Standard Test Method for Residual powder in the gloves
Powder on Medical Gloves

Physical ASTM D6319-19 To Determine the Befo
Properties Standard Specification for Nitrile physical properties- Tens
Examination Gloves for Medical Tensile strength Minim
Application
After
Stren
Minim

To Determine the Befo
physical properties- Ultim
Ultimate Elongation 500%

After
Elong
for al

THAI MEDICAL GLOVE CO., LTD. (BANG PHRA FACTORY)

363/2 Moo 8, Tambol Bangphra, Sriracha, Chonburi, THAILAND 20110

Attachment 17
Page 6 of 7

eptance Criteria Result Status

g per glove or less Sample size : 5 pcs Pass

ore Ageing Requirement: 2 mg per glove or less Pass
sile Strength 14Mpa
mal for all sizes Result : Pass
r Ageing Tensile
ngth 14Mpa Small:1.42 mg/glove
mal for all sizes Medium: 0.50 mg/glove
Large: 1.34 mg/glove
ore Ageing Extra Large:1.36 mg/glove
mate Elongation
% Min for all sizes Before Ageing
Small: 18.37 MPa
r Ageing Ultimate Medium: 30.62 MPa
gation 400% Min Large: 18.30 MPa
ll sizes Extra Large: 18.20 MPa

After ageing:
Small: 14.08 MPa
Medium: 31.89 MPa
Large: 14.00 MPa
Extra Large: 14.00 MPa

Before Ageing:
Small: 612%
Medium: 500 %
Large:620%
Extra Large:587%

After ageing:
Small:408%
Medium: 499%
Large:403%
Extra Large:416%

www.thaimedicalglove.co.th
[email protected]

Page 7 of 7

8.0 Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

9.0 Conclusion
The conclusions drawn from the non-clinical test demonstrate that the subject device TMG Nitrile
Powder Free Examination Glove is as safe, as effective, and performs as well as or better than the
legally marketed predicate device K202384.

THAI MEDICAL GLOVE CO., LTD. (BANG PHRA FACTORY) www.thaimedicalglove.co.th
[email protected]
363/2 Moo 8, Tambol Bangphra, Sriracha, Chonburi, THAILAND 20110

Test Report No. 5162189 Date : 28-Jan-2022 Testing 0013
SGS (Thailand) Limited

Page 1 of 4

Client : THAI MEDICAL GLOVE CO.,LTD.
61/160 RAMA IX ROAD,
HUAY KHWANG, HUAY KHWANG, BANGKOK 10310 THAILAND

The following sample(s) was/were submitted and identified by client as:

Sample Name : Nitrile glove
Sample Description : Nitrile glove
Batch/Lot No. : 211223
Color : Blue
Manufacturer/Vendor : Thai medical glove
Country of Origin : Thailand

The following sample(s) was/were identified by SGS as:

SGS Sample No. : 5377018

Sample Condition : Sample is contained in a plastic bag

Quantity Submitted : 1 pack

Sample Receiving Date : 21-Jan-2022

Testing Period : 21-Jan-2022 to 28-Jan-2022

Test Method & Results : Please refer to next page(s).

4863902 "Any holder of this document is advised that should client or third party information be supplied with respect to the goods or sample, SGS may,
at its discretion, attached or indicate such information to the report but SGS makes no warranties or accepts no liable for the veracity or lack

“This document is issued by the Company subject to its General Conditions of Service printed overleaf , available on request or accessible at http:// www.sgs.com/en/Terms-and-Conditions.aspx and, for electronic
format documents, subject to Terms and Conditions for Electronic Documents at http:// www.sgs.com/en/Terms-and-Conditions/Terms-e-Document.aspx

Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at
the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising
all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or
falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law.”

Unless otherwise stated the results shown in this test report refer only to the sample(s) received and such sample(s) are retained for 30 days only.

Test Report No. 5162189 Date : 28-Jan-2022 Testing 0013
SGS (Thailand) Limited

Page 2 of 4

Test Requested & Result Summary

Test Requested : Please refer to the result summary (Test parameter(s) was/were selected by client).

Result Summary:

Test Requested Conclusion
US FDA 21 CFR 177.2600 (Rubber Articles)- --
Determination of Amount of Extractives
- Distilled Water Extractants PASS
- n-Hexane Extractants PASS

Remark:
1.Test results in this report are applicable for the item tested and reflects the tested sample as received.
2.The decision rules based on simple acceptance which the probability of false accept may be as high as 50% in
case the results is exactly on the tolerance limit.

Signed for and on behalf of
SGS (Thailand) Limited

Rutchuporn Moungsom
Laboratory manager - Hardgood

4863902 "Any holder of this document is advised that should client or third party information be supplied with respect to the goods or sample, SGS may,
at its discretion, attached or indicate such information to the report but SGS makes no warranties or accepts no liable for the veracity or lack

“This document is issued by the Company subject to its General Conditions of Service printed overleaf , available on request or accessible at http:// www.sgs.com/en/Terms-and-Conditions.aspx and, for electronic
format documents, subject to Terms and Conditions for Electronic Documents at http:// www.sgs.com/en/Terms-and-Conditions/Terms-e-Document.aspx

Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at
the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising
all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or
falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law.”

Unless otherwise stated the results shown in this test report refer only to the sample(s) received and such sample(s) are retained for 30 days only.

Test Report No. 5162189 Date : 28-Jan-2022 Testing 0013
SGS (Thailand) Limited
TEST RESULTS
Page 3 of 4

US FDA 21 CFR 177.2600 (Rubber Articles)-Determination of Amount of Extractives***

Method : With reference to US FDA 21 CFR 177.2600.

For use in contact with aqueous foods :

Extractants Test Condition Result (1) Reporting Limit Permissible Limit
(mg/inch2) (mg/inch2) (mg/inch2)
Distilled Water Reflux temperature
Distilled Water for 7 hours 1.0 0.3 20

Comment Succeeding 2 hours 0.5 0.3 1
of extraction
PASS -- --
--

For use in contact with fatty foods :

Extractants Test Condition Result (1) Reporting Limit Permissible Limit
(mg/inch2) (mg/inch2) (mg/inch2)

n-Hexane Reflux temperature 0.4 0.3 175

for 7 hours

n-Hexane Succeeding 2 hours <0.3 0.3 4
of extraction

Comment -- PASS -- --

Sample Description :
1. Blue rubber glove

Note : 1. mg/inch2 = milligram per square inch
2. < = Less than

Remark: The test item(s) marked *** on test report is/are analyzed at SGS (Thailand) Limited, address: 41/16-20 and
41/23 Soi Rama III 59, Rama III road, Chongnonsee, Yannawa, Bangkok.

4863902 "Any holder of this document is advised that should client or third party information be supplied with respect to the goods or sample, SGS may,
at its discretion, attached or indicate such information to the report but SGS makes no warranties or accepts no liable for the veracity or lack

“This document is issued by the Company subject to its General Conditions of Service printed overleaf , available on request or accessible at http:// www.sgs.com/en/Terms-and-Conditions.aspx and, for electronic
format documents, subject to Terms and Conditions for Electronic Documents at http:// www.sgs.com/en/Terms-and-Conditions/Terms-e-Document.aspx

Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at
the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising
all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or
falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law.”

Unless otherwise stated the results shown in this test report refer only to the sample(s) received and such sample(s) are retained for 30 days only.

Test Report No. 5162189 Date : 28-Jan-2022 Testing 0013
SGS (Thailand) Limited

Page 4 of 4

SAMPLE/ATTACHMENT PICTURE

4863902 ****************************************** End of Report ******************************************

"Any holder of this document is advised that should client or third party information be supplied with respect to the goods or sample, SGS may,
at its discretion, attached or indicate such information to the report but SGS makes no warranties or accepts no liable for the veracity or lack

“This document is issued by the Company subject to its General Conditions of Service printed overleaf , available on request or accessible at http:// www.sgs.com/en/Terms-and-Conditions.aspx and, for electronic
format documents, subject to Terms and Conditions for Electronic Documents at http:// www.sgs.com/en/Terms-and-Conditions/Terms-e-Document.aspx
Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at
the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising
all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or
falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law.”
Unless otherwise stated the results shown in this test report refer only to the sample(s) received and such sample(s) are retained for 30 days only.

Acknowledgment Letter

11/1/2021

Noppadol Polbundit, Operation Director
Thai Medical Glove Co., Ltd.
363/2 Moo 8, Tambol Bangphra
Sriracha, Chonburi 20110
THAILAND

Dear Noppadol Polbundit:

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration
(FDA) has received your submission. This submission has been assigned the unique document
control number below. All future correspondence regarding this submission should be identified
prominently with the number assigned and should be submitted to the Document Control
Center at the address listed below. Failure to do so may result in processing delays. If you
believe the information identified below is incorrect, please contact the Office of Product
Evaluation and Quality (OPEQ) submission support at (301) 796-5640 or
[email protected].

Submission Number: K213500
Received: 11/1/2021
Applicant: Thai Medical Glove Co., Ltd.
Device: TMG Nitrile Powder Free Examination Glove

We will notify you when the review of this document has been completed or if any additional
information is required. For information about CDRH review regulations and policies, please
refer to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.

Sincerely yours,

Center for Devices and Radiological Health

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

0

DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved. OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
See PRA Statement below.
Indications for Use

510(k) Number (if known)

K213500

Device Name
TMG NITRILE POWDER FREE EXAMINATION GLOVE

Indications for Use (Describe)
TMG nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the
examiner's hand to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable) X, Over-The-Counter Use (21 CFR 801 Subpart C)
1 Prescription Use (Part 21 CFR 801 Subpart D)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]

"An agency may not conduct or sponsor, and a person is not required to respond to. a collection of
information unless it displays a currently valid OMB number.
"

FORM FDA 3881 (6/20) Page 1 o f 1

February 21, 2022

Thai Medical Glove Co., Ltd.
Noppadol Polbundit
Operation Director
363/2 Moo 8, Tambol Bangphra
Sriracha, Chonburi 20110
Thailand

Re: K213500
Trade/Device Name: TMG Nitrile Powder Free Examination Glove
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved
Product Code: LZA
Dated: October 14, 2021
Received: November 1, 2021

Dear Noppadol Polbundit:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

U.S. Food & Drug Administration Doc ID# 04017.04.32
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

K213500 - Noppadol Polbundit Page 2

801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD
Assistant Director
DHT4B: Division of Infection Control

and Plastic Surgery Devices
OHT4: Office of Surgical

and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Test report Tester : PUS
Note : Before Aged
Customer : Thai Medical Glove
Test Date : 15 Dec 2021
Test standard : ASTM D412-C

Test speed : 500 mm/min

Test results:

Thickness Tensile at break Elong at break 25 % 50 % 100 % 200 % 300 % 400 % 500 % 600 %

No. mm MPa % MPa MPa MPa MPa MPa MPa MPa MPa

1 0.086 27.01 545 0.98 1.45 2.03 2.97 4.48 7.63 17.16 -

2 0.09 27.28 542 0.97 1.46 2.07 3.07 4.74 7.98 18.00 -

3 0.084 29.20 539 1.04 1.59 2.26 3.40 5.20 9.27 20.80 -

4 0.089 27.39 535 1.01 1.53 2.17 3.39 5.16 8.90 19.67 -

5 0.092 28.28 542 1.03 1.56 2.21 3.30 5.09 8.62 19.16 -

Series graph:

25

20

Stress in MPa 15

10

5

0 100 200 300 400 500
0 Strain in %

Statistics:

Series Thickness Tensile at break Elong at break 25 % 50 % 100 % 200 % 300 % 400 % 500 % 600 %
n=5 MPa MPa MPa MPa MPa MPa MPa MPa
mm MPa % 1.01 1.52 2.15 3.23 4.93 8.48 18.96 -
x 0.03 0.06 0.10 0.20 0.31 0.67 1.42 -
s 0.0882 27.83 540 2.97 4.09 4.46 6.08 6.34 7.87 7.50 -

 0.003194 0.9013 4 1.01 1.53
0.97 1.45
med 3.62 3.24 0.74 1.04 1.59
min
max 0.089 27.39 542 2.17 3.30 5.09 8.62 19.16 -
0.084 27.01 535 2.03 2.97 4.48 7.63 17.16 -
0.092 29.20 545 2.26 3.40 5.20 9.27 20.80 -

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