Predicate Devices

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard patient examination glove and the description and testing focus on material properties and physical performance, with no mention of AI or ML.

Therapeutic

No.
A therapeutic device is one that treats or prevents a disease or condition. This device is an examination glove, which is intended to prevent contamination, not to treat or prevent a medical condition in the patient or examiner.

Diagnostic

No

Explanation: The device is a patient examination glove, described as a disposable device worn on the examiner's hand to prevent contamination. Its function is not to diagnose any condition, but rather to serve as a barrier. The performance studies and key metrics listed relate to the physical properties and safety of the glove, not its ability to detect or identify medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made of nitrile, not a software application. The description details material properties and physical tests, not software functionalities.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to be worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
Device Description: The description focuses on the physical properties and materials of the glove. There is no mention of reagents, assays, or any components used to analyze biological samples.
Performance Studies: The performance studies focus on the physical integrity, biocompatibility, and freedom from holes of the glove. These are relevant to a barrier device, not an IVD.
Key Metrics: The key metrics relate to physical properties, powder content, and biocompatibility, not diagnostic performance metrics like sensitivity or specificity.

IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This glove does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Product codes

LZA

Device Description

Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).

The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface.

These gloves are blue in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical tests were carried out to demonstrate product performance conformity with standards referenced.
The following bench tests were performed:
Non-clinical tests

Residual Powder Content A
Physical Properties
Physical Dimension
Freedom from Holes

Biocompatibility Testing

Animal Irritation Test
Dermal Sensitization Assay
Acute Systemic Toxicity

The results from these performance evaluations demonstrated that the Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, met the acceptance criteria defined in standards referenced.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K210369

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 30, 2022

Tec Gloves Industry (M) Sdn.Bhd. Eunice Arumugam Regulatory Manager Lot 35793, Jalan Sungai Batu 31/KU6, Kawasan Perindustrian Klang Utama Klang, Selangor 42100 Malaysia

Re: K221378

Trade/Device Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 11, 2022 Received: July 11, 2022

Dear Eunice Arumugam:

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

1

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 801); medical device 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-reportingcombination-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bifeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221378

Device Name Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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 PRAStaff(@fda.hhs.gov

"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."

3

Image /page/3/Picture/1 description: The image shows the logo for TEC Gloves. The logo features the text "TEC GLOVES" in a stylized font, with "TEC" in red and "GLOVES" in blue. To the left of the text is a semi-circular design made of blue and red dots. There is a trademark symbol to the right of the word "GLOVES".

LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA

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Premarket Notification [510(k)] No: K221378

510 (K) SUMMARY

1.0 Device Name:

Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile.

2.0 Submitter name / Contact details

TEC GLOVES INDUSTRY (M) SDN. BHD.

Lot 35793, Jalan Sungai Batu 31/KU6, Kawasan Perindustrian Klang Utama, 42100 Klang, Selangor. MALAYSIA

Contact Person Details: Eunice Varaletchumi Arumugam (Ms) E-mail: regulation@tecglovesusa.com Tel: +60-1-93121218 Fax: Nil

3.0 Summary Preparation Date:

April 28, 2022

4.0 Device Name & Classification:

Trade Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-sterile Common Name: Nitrile Powder Free Patient Examination Glove Device Name: Polymer Patient Examination Gloves Device Classification: Class I Requlation Number: 21 CFR 880.6250 Panel: General Hospital Product Code: LZA

5.0 Identification of The Legally Marketed Device:

Predicate Device Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-sterile Predicate 510(K) Number: K210369 Manufacture's Name: Pastel Glove Sdn Bhd

4

Image /page/4/Picture/1 description: The image shows the logo for TEC Gloves. The logo features the text "TEC GLOVES" in a stylized font. The word "TEC" is in red, while the word "GLOVES" is in blue. To the left of the text is a semi-circular design made up of blue and red dots. The letters in the logo are blocky and modern.

LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA +60 11-5725 2513 ए www.tecgloves.com

6.0 Description of Device

Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).

The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface.

These gloves are blue in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

7.0 Indications for Use:

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

8.0 Summary of the Technological Characteristic of the Device

Image /page/4/Picture/10 description: The image shows a crescent shape made of light blue and pink circles. The circles vary in size, with some being larger and some being smaller. The circles are arranged in a curved pattern, with the larger circles at the bottom and the smaller circles at the top. The background is white.

5

Image /page/5/Picture/1 description: The image shows the logo for TEC Gloves. The word "TEC" is in red, and the word "GLOVES" is in blue. To the left of the word "TEC" is a semi-circle made of red and blue dots. The letters are blocky and modern.

LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA

+60 11-5725 2513 ए www.tecgloves.com ക

| able

| 1 |
|-----------|---|
|-----------|---|

| Characteristics and
Parameters | Standard | Proposed Device | Predicate device | Comparison
Analysis |
|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| 510(k) Number | - | K221378 | K210369 | - |
| Name of device | - | Nitrile Powder Free
Blue Patient
Examination Gloves,
Non-Sterile | Powder Free Nitrile
Examination Gloves
Non-Sterile | Similar |
| Device Classification
Name/Regulation
Number | Patient Examination
Glove,
21 CFR Part
880.6250 | Patient Examination
Glove,
21 CFR Part 880.6250 | Patient Examination
Glove,
21 CFR Part 880.6250 | Similar |
| Product Code | - | LZA | LZA | Similar |
| Intended Use | - | A patient examination
glove is a disposable
device intended for
medical purpose that
is worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner | A patient examination
glove is a disposable
device intended for
medical purpose that
is worn on the
examiner's hand or
finger to prevent
contamination
between patient and
examiner. | Same intended
use |
| Classification | - | Class 1 | Class 1 | Same Class |
| Raw Rubber Material | ASTM D 6319-19 | Nitrile (Acrylonitrile-
butadiene) | Nitrile (Acrylonitrile-
butadiene) | Same synthetic
rubber material |
| Design, Color and
Surface Appearance | - | 1. Ambidextrous
2. Blue
3. Powder Free
4. Finger Textured | 1. Ambidextrous
2. Blue
3. Powder Free
4. Finger Textured | Same,
ambidextrous
design, same
color,
same features
and same
textured area |
| Overall Length
(Minimum 230mm) | ASTM D 6319-19 | Average 245mm,
all sizes | Average: 242 mm | Similar |
| Palm (mm)
XS: 60 - 80mm
S: 75 — 95mm
M: 85 — 105mm
L: 100 — 120mm
XL: 110 — 130mm
XXL: 120 - 140mm | ASTM D 6319-19 | XS : 77 – 78mm
S : 83 — 85mm
M : 94 - 96mm
L : 107 — 108mm
XL: 117 — 118mm
XXL: 124 — 125mm | XS: NA
S: 84mm
M: 94mm
L: 103mm
XL: NA
XXL: NA | Similar, subject
device meet
requirement of
ASTM D6319 |
| Palm Thickness
(Minimum 0.05mm) | ASTM D 6319-19 | Average 0.06mm,
all sizes | Average: 0.06mm | Similar |
| Finger Thickness
(Minimum 0.05mm) | ASTM D 6319-19 | Average 0.09mm,
all sizes | Average: 0.08mm | Similar |
| Characteristics and
Parameters | Standard | Proposed Device | Predicate device | Comparison
Analysis |
| Tensile Strength
(Before aging)
Minimum 14 MPa | ASTM D 6319-19 | Average: 22.24 MPa | Average: 17.75 MPa | Similar |
| Tensile Strength
(After accelerated aging
Minimum 14 MPa | ASTM D 6319-19 | Average: 26.46 MPa | Average: 16.07MPa | Similar |
| Ultimate Elongation
(before aging)
Minimum 500% | ASTM D 6319-19 | Average: 533 % | Average: 560 % | Similar |
| Ultimate Elongation
(after accelerated aging
Minimum 400% | ASTM D 6319-19 | Average: 476 % | Average:510 % | Similar |
| Freedom of Holes Meet
AQL 2.5 at G1 | ASTM D 5151-19 | Meet AQL 1.5 with G1 | Meet AQL 1.5 with G1 | Similar |
| Residual powder test (L
than 2mg/glove) | ASTM D 6124-06 | Average powder residue
for each size.
XS : 0.36 mg/glove
S : 0.32 mg /glove
M : 0.36 mg /glove
L : 0.30 mg /glove
XL : 0.32 mg/glove
XXL: 0.30 mg/glove | Average powder
residue for each size
XS : Nil
S : 0.45 mg/glove
M : 0.43 mg/glove
L : 0.27 mg/glove
XL : Nil
XXL: Nil | Similar |
| Animal Irritation Test | ISO 10993-10
Biological evaluation
of medical devices -
Part 10: Tests for
irritation and skin
Sensitization | Passed.
Under the conditions of
study, not an irritant | Passed.
Under the conditions
of study, not an
irritant | Similar |
| Dermal Sensitization | ISO 10993-10
Biological evaluation
of medical devices -
Part 10: Tests for
irritation and skin
sensitization | Passed.
Under the conditions of
study, not a sensitizer | Passed.
Under the conditions
of study, not a
sensitizer | Similar |
| Acute Systemic Toxicity | ISO 10993-11
Biological evaluation
of medical devices –
Part 11: Tests for
systemic toxicity | Not induce systemic
toxicity | Not induce systemic
toxicity. | Similar |
| Expiration Date | ASTM D 7160-16
Standard Practice for
Determination of
Expiration Dating for
Medical Gloves | 3 years from date of
manufactured | Predicate device
has not stated. | - |
| Manufacturer | - | Tec Gloves Industry (M)
Sdn. Bhd. | Pastel Glove Sdn Bhd | - |

6

Image /page/6/Picture/1 description: The image shows the logo for TEC Gloves. The logo features the text "TEC GLOVES" in a stylized font. The word "TEC" is in red, and the word "GLOVES" is in blue. To the left of the text is a semi-circular design made up of red and blue dots. The letters TM are in the upper right corner of the word "GLOVES".

LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA

+60 11-5725 2513 ए www.tecgloves.com

7

Section 006 Page 5 of 8

Image /page/7/Picture/1 description: The image shows the logo for TEC Gloves. The word "TEC" is in red, and the word "GLOVES" is in blue. To the left of the word "TEC" is a semi-circle made of red and blue dots. The letters "TM" are in the upper right corner of the image.

LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA

+60 11-5725 2513 ए www.tecgloves.com

9.0 Summary of Non-Clinical Testing

Table 2 -Performance Testing

Non-Clinical Testing
Test Method	Purpose	Acceptance Criteria	Result
ASTM D6124-06
(Reapproved 2017)
Standard Test
Method for Residual
Powder on Medical
Gloves.	To determine the
residual powder in the
gloves	Less than 2mg / glove	Size XS 0.36mg/glove
Size S 0.32mg/glove
Size M 0.36mg/glove
Size L 0.30mg/glove
Size XL 0.32mg/glove
Size XXL 0.30 mg/glove
ASTM D5151-19
Standard Test Method
for Detection of Holes in
Medical Gloves.	To determine the holes
in the gloves	Inspection level, G-I AQL 2.5
(In accordance with ASTM
D6319-19)	Passed G-I, AQL 1.5
ASTM D6319-19
Standard Specification for
Nitrile Examination Gloves
for Medical Application.	To determine the length
of the gloves	Size XS 220mm, min
Size S 220mm, min
Size M 230mm, min
Size L 230mm, min
Size XL 230mm, min	Size XS 246 – 250mm
Size S 248 – 252mm
Size M 250 – 252mm
Size L 248 – 251mm
Size XL 245 – 248mm
Size XXL 245 – 248mm
ASTM D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application.	To determine the width
of the gloves	Size XS 70 ± 10mm
Size S 80 ± 10mm
Size M 95 ± 10mm
Size L 110 ± 10mm
Size XL 120 ± 10mm
Size XXL 130 ± 10mm	Size XS XS: 77 - 78mm
Size S S: 83 – 85mm
Size M M: 94 – 96mm
Size L L: 107 – 108mm
Size XL XL: 117 – 118mm
Size XXL XXL:124 – 125mm
Non-Clinical Testing (Cont'd)
Test Method	Purpose	Acceptance Criteria	Result
ASTM D6319-19
Standard
Specification for
Nitrile Examination
Gloves for Medical
Application.	To determine the
thickness of the
gloves	Measured in single wall at approximate center of palm area
Palm 0.06mm, min	Size XS 0.06 – 0.07 mm
Size S 0.06 – 0.07 mm
Size M 0.06 – 0.07 mm
Size L 0.06 – 0.07 mm
Size XL 0.06 – 0.07 mm
Size XXL 0.06 – 0.07 mm
		Measured in single wall at 13±3mm from the tip of middle finger region
Finger 0.07mm, min	Size XS 0.08 – 0.09 mm
Size S 0.08 – 0.09 mm
Size M 0.08 – 0.10 mm
Size L 0.08 – 0.10 mm
Size XL 0.08 – 0.10 mm
Size XXL 0.08 – 0.11 mm
ASTM D6319-19
Standard
Specification for
Nitrile Examination
Gloves for Medical
Application.	To determine the
physical properties-
Tensile strength	Before Ageing
Tensile Strength 14Mpa,
for all sizes	Size XS 21.67 MPa, average
Size S 21.67 MPa, average
Size M 22.14 MPa, average
Size L 22.61 MPa, average
Size XL 22.99 MPa, average
Size XXL 22.35 MPa, average
		After Ageing
Tensile Strength 14Mpa,
for all sizes	Size XS 30.67 MPa, average
Size S 27.80 MPa, average
Size M 26.73 MPa, average
Size L 22.44 MPa, average
Size XL 23.15 MPa, average
Size XXL 27.98 MPa, average
	To determine the
physical properties-
Ultimate Elongation	Before Ageing Ultimate
Elongation 500%, min for
sizes	Size XS 547%, average
Size S 529%, average
Size M 533%, average
Size L 523%, average
Size XL 524%, average
Size XXL 540%, average
		After Ageing
Ultimate Elongation 400%,
min for all sizes	Size XS 453%, average
Size S 463%, average
Size M 448%, average
Size L 519%, average
Size XL 516%, average
Size XXL 458%, average

8

Section 006 Page 6 of 8

Image /page/8/Picture/1 description: The image shows the logo for TEC Gloves. The logo consists of the words "TEC GLOVES" in a stylized font. The word "TEC" is in red, and the word "GLOVES" is in blue. To the left of the words is a circular design made up of blue and red dots. The letters TM are in the upper right corner of the logo.

LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA

+60 11-5725 2513 ए www.tecgloves.com

9

Section 006 Page 7 of 8

Image /page/9/Picture/1 description: The image shows the logo for TEC Gloves. The logo has the word "TEC" in red and the word "GLOVES" in blue. There are blue and red dots arranged in a semi-circle around the word "TEC". The letters are in a sans-serif font.

LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA

+60 11-5725 2513 www.tecgloves.com

Biocompatibility Testing
Test Method	Purpose	Acceptance Criteria	Result
ISO 10993-10
Biological evaluation
of medical devices -
Part 10: Tests for
irritation and skin
sensitization
(Animal Irritation
Test)	To determine the
potential of the
material under
test to produce
dermal irritation
in Rabbits	Under the condition of
study not an irritant.	There was no observable
irreversible alteration on the
skin at the sites of contact with
the test material. The Primary
Irritation Index (PII) was "0".
The test material was not
irritant, and the Primary
Irritation Response Category is
therefore "negligible", thereof
met the requirement.
ISO 10993-10
Biological evaluation
of medical devices -
Part 10: Tests for
irritation and skin
sensitization
(Dermal
Sensitization
Assay Test)	To determine the
skin sensitization
potential of the
material both in
terms of induction
and elicitation in
Guinea pig	Under the condition of
the study not a
sensitizer.	There was no sensitization
induced by the application of
the test material on the albino
guinea pigs under the condition
of this test, thereof met the
requirement.
ISO 10993-11
Biological evaluation
of medical devices -
Part 11: Tests for
systemic toxicity
(Acute Systemic
Toxicity)	To provide
information on
health hazards
likely to arise from
a short-term
exposure to the
extracts of test
material by
intravenous and
intraperitoneal
injection in mice	Not induce systemic
toxicity	Under the condition of this
study, the single dose acute
systemic toxicity of extracts
from test material using both
normal saline and sesame oil,
did not demonstrate any
adverse toxic reaction, thereof
met the requirement.

Non-Clinical tests were carried out to demonstrate product performance conformity with standards referenced.

The following bench tests were performed:

Non-clinical tests

Residual Powder Content A
ハ Physical Properties
Physical Dimension
Freedom from Holes

Biocompatibility Testing

Animal Irritation Test
Dermal Sensitization Assay
Acute Systemic Toxicity

The results from these performance evaluations demonstrated that the Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, met the acceptance criteria defined in standards referenced.

10

Section 006 Page 8 of 8

Image /page/10/Picture/1 description: The image shows the logo for TEC Gloves. The word "TEC" is in red, and the word "GLOVES" is in blue. To the left of the word "TEC" is a semi-circle made of blue and red dots. To the right of the word "GLOVES" is the trademark symbol.

LOT 35793 JALAN SUNGAI BATU 31/KU6 KAWASAN PERINDUSTRIAN KLANG UTAMA 42100 KLANG - MALAYSIA

+60 11-5725 2513 ए www.tecgloves.com

10.0 Summary of Clinical Testing:

Clinical Testing is not needed for this device.

11.0 Conclusion

The conclusion drawn from the non-clinical test demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K2210369.

Image /page/10/Picture/8 description: The image shows a crescent shape made of light blue and pink circles. The circles vary in size, with the larger circles at the bottom and the smaller circles at the top. The crescent shape is open on the right side. The background is white.