Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.

Therapeutic

No
The device is described as a disposable glove worn on the hand to prevent contamination; it does not mention any therapeutic action or benefit.

Diagnostic

No
The device, Powder Free Blue Nitrile Examination Gloves, is described as a disposable device worn on the examiner's hand to prevent contamination, which is a protective barrier function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device is a physical product (nitrile examination gloves) and the description focuses on material properties, manufacturing standards, and physical performance tests, not software functionality.

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 clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
Device Description: The description focuses on the physical properties of the glove (watertight, tensile properties, conforming to the hand) and its manufacturing standards, all related to its barrier function.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's condition.
Performance Studies: The performance studies listed focus on biological evaluation (irritation, sensitization, toxicity) and physical properties (powder residue, holes, tensile strength), which are relevant to a barrier device, not a diagnostic one.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Powder Free Blue Nitrile Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

Product codes (comma separated list FDA assigned to the subject device)

LZA

Device Description

The nitrile rubber is watertight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for the medical properties. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319-19 and ASTM D5151-19. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

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 conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for Irritation and Skin Sensitization.
ISO 10993-11- Biological Evaluation of Medical devices- Part 11: Tests for Systemic toxicity.
ASTM D6124-06 (Reapproved 2017), Standard test method for Residual powder on medical gloves.
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

Performance Testing - Animal Studies:

Guinea Pig Sensitization: No reaction was observed upon removal of the test material and there was no positive allergic reaction observed on the test of guinea pigs during the challenge phase. None of the guinea pigs was sensitized. Conclusion: meets conformance requirements.
Primary Dermal Irritation in Rabbits: Primary Irritation Index was 0. Conclusion: meets conformance requirements.
Acute Systemic Cytotoxicity in Rats: All animals survived and appeared healthy and active throughout of 4 days. All animals gained body weight. Gross necropsies showed no abnormalities for any of the animals. Conclusion: meets conformance requirements.

ASTM D5151-19 Pinhole Test: Pass (Free from holes, AQL 1.5)
ASTM D6319-19 Physical Properties: Pass

Before Aging: Tensile Strength: Min 14 MPa, Elongation: Min 500%
After Aging: Tensile Strength: Min 14 MPa, Elongation: Min 400%
ASTM D6124-06 Powder Residue: Pass (2 mg/glove maximum)

Performance data of gloves based on ASTM D6319-19 and FDA Watertight Test:

Watertight (1000mL) in accordance with ASTM D5151-19: Pass G1: AQL 2.5
Length: All sizes (S, M, L, XL) are 240mm minimum (meets/exceeds Min 220mm for S, Min 230mm for M, L, XL)
Palm width:
- Size S: 84 – 86 (meets 80 ± 10)
- Size M: 95-96 (meets 95 ± 10)
- Size L: 108 – 109 (meets 110 ± 10)
- Size XL: 114 - 115 (meets 120 ± 10)
Thickness (Single Layer):
- Finger: Min 0.06 (meets Min 0.05)
- Palm: Min 0.06 (meets Min 0.05)
- Cuff: Min 0.05 (meets Min 0.05)
Physical Properties in accordance with ASTM D412-16:
- Before Aging: Tensile Strength (MPa) 17 – 23 (meets Min 14), Ultimate Elongation (%) 540 – 607 (meets Min 500)
- After Aging: Tensile Strength (MPa) 21 – 27 (meets Min 14), Ultimate Elongation (%) 480 - 565 (meets Min 400)
Powder Content in accordance with ASTM D6124-06: Below 2.0 mg/ glove (meets Max 2.0 mg/ glove)

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K172930

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 22, 2022

Lienteh Technology Sdn Bhd Irsyad Mazuki Senior RA Executive Lot 6483. Jalan Sungai Puloh KU 5. Kawasan Perindustrian Sungai Puloh Klang, Selangor 42100 Malaysia

Re: K213678

Trade/Device Name: Powder Free Blue Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 4, 2022 Received: March 14, 2022

Dear Irsyad Mazuki:

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

1

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 (OS) 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,

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

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)

K213678

Device Name Powder Free Blue Nitrile Examination Gloves

Indications for Use (Describe)

Powder Free Blue Nitrile Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand 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."

FORM FDA 3881 (6/20)

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Image /page/3/Picture/0 description: The image shows the logo for Lienteh Technology SDN BHD. The logo features a blue circle with a white hand inside, along with the company name in bold, black letters. Below the logo is the company's registration number, K213678.

K213678 510k Summary

As required by 21 CFR 807.92

1) Submission Information:

Date	: 11th October 2021
Type of 510(k) Submission : Traditional
Basis for 510(k) Submission : New Device
Applicant	: Lienteh Technology Sdn Bhd
Lot 6483 Jalan Sg Puloh, KU5 Kawasan Perindustrian,
Lorong Sungai Puloh, 42100 Klang, Selangor.
Contact Person	: Mohd Irsyad (Regulatory Affairs cum Senior QA Engineer)
Lot 6483 Jalan Sg Puloh, KU5 Kawasan Perindustrian,
Lorong Sungai Puloh, 42100 Klang, Selangor.

E-mail: irsyadmazuki@lienteh.com

Tel: +6014-5157 058

1) Device:

Proprietary Name: Powder Free Blue Nitrile Examination Gloves Classification Name: Examination Gloves Regulation Number: 880.6250 Product code: LZA Device Class: I Review panel: General Hospital

2) Device Description

The nitrile rubber is watertight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for the medical properties. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319-19 and ASTM D5151-19. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.

3) Identification of the Legally Marketed Devices

Class 1 Nitrile Patient Examination Gloves LZA, powder free that meets all the requirements of ASTM standard D6319-19 and FDA water leak test.

4) The Intended Use of Gloves

A medical glove is worn on the examiner's hand to prevent contamination between patient and examiner.

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Image /page/4/Picture/0 description: The image contains the logo for Lienteh Technology SDNBHD. The logo features the company name in bold, black, italicized font. To the left of the company name is a circular graphic with a white hand design inside of it, with the words "Lienteh Technology" written below.

Technological Characteristics:

Table 1: General Comparison

Technological characteristics Comparison to Predicate Device
	Subject Device	Predicate Device	Comparison
	Lienteh Technology
Sdn Bhd's Powder Free
Blue Nitrile
Examination Gloves	Mercator Medical
(Thailand) LTD's
mCare Powder Free
Nitrile Blue
Examination Gloves -
510K Number	K213678	K172930
Indications for Use	Powder Free Blue Nitrile
Examination Gloves are
disposable device intended
for medical purposes that
are worn on the
examiner's hand to prevent
contamination between
patient and examiner.	The device is a
disposable device
intended for medical
purposes that are worn
on the examiner's hand
to prevent
contamination between
patient and examiner.	Same
Design Specification	Meet ASTM D6319-19	Meet ASTM D6319-19	Same
Performance
Physical Properties	Meet ASTM D6319-19	Meet ASTM D6319-19	Same
Material of
Composition	Synthetic Nitrile
Rubber	Synthetic Nitrile
Rubber	Same
Biocompatibility:
Animal Irritation
Test Rabbit	Under the condition of
study, not an irritant	Under the condition of
study, not an irritant	Same
Dermal Sensitization
Test- Guinea Pig	Under the condition of
study, not a sensitizer	Under the condition of
study, not a sensitizer	Same
Acute Systemic
Cytotoxicity	Under the condition of
the study, no adverse
biological reaction	Under the condition of
the study, no adverse
biological reaction	Same
Color	Synthetic gloves with
embedded colorant-
Blue	Synthetic gloves with
embedded colorant-
Blue	Same
Sterility	Non-Sterile	Non-Sterile	Same
Powder Free	Meets applicable
definition for Powder
free; ≤ 2mg per glove	Meets applicable
definition for Powder
free; ≤ 2mg per glove	Same
Labelling
Information	Single Use indication,
Powder free, device
name, gloves size,
quantity, Patient
examination gloves,
Non-sterile	Single Use indication,
Powder free, device
name, gloves size,
quantity, Patient
examination gloves,
Non-sterile	Same
Physical Properties
as per ASTM
D6319-19	Before Aging
Tensile Strength
Min 14 MPa
Ultimate Elongation
Min 500%	Before Aging
Tensile Strength
Min 14 MPa
Ultimate Elongation
Min 500%	Same
	After Aging
Tensile Strength
Min 14 MPa
Ultimate Elongation
Min 400%	After Aging
Tensile Strength
Min 14 MPa
Ultimate Elongation
Min 400%
Dimension as per
ASTM D6319-19	Finger Thickness:
0.06 - 0.10 mm
Length: min 230 mm	Finger Thickness:
Min 0.05 mm
Length: min 230 mm	Similar
Freedom from holes	AQL per CFR
21.800.20
Test as per ASTM
D5151-19	AQL per CFR
21.800.20
Test as per ASTM
D5151-19	Same
Residual Powder	Tested to ASTM D6124
and meets requirement	Tested to ASTM D6124
and meets requirement	Same

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Image /page/5/Picture/0 description: The image contains a logo for Lienteh Technology. The logo features a blue circle with a white hand inside, above a red curved line. Below the logo, the word "LIENTEH" is written in a stylized font, with the word "TECHNOLOGY" written in smaller letters below it.

LIENTEH TECHNOLOGY SDNBHD

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Image /page/6/Picture/0 description: The image shows the logo for Lienteh Technology SDN BHD. The logo features a blue and red circular graphic to the left of the company name. The text "Lienteh Technology SDN BHD" is written in a bold, sans-serif font, with the words "Lienteh" and "Technology" being larger than "SDN BHD". The logo appears to be for a technology company.

The biocompatibility test consists of Animal Irritation Test, Guinea Pig Sensitization . (Buehler), and Acute Systemic Toxicity test were conducted and test reports are attached. The gloves pass the Biocompatibility test criteria of not being Sensitizers or irritants under the conditions of the test and no adverse biological reaction observed during the period of the study.
Conclusion .

We concluded that the Non sterile, Powder Free Blue Nitrile Examination Gloves meet:

ASTM D6319-19 standard for
- Watertight test for pinholes.
- Physical properties. .
- " Dimensions.
- Residual Powder. ■

6) Non-clinical test was performed on the proposed device:

The proposed device was tested and conformed to the following standards and requirements stated in guidance for industry passed and FDA staff - Premarket Notification [510(k)] Submission issued on March 5, 2004:

Table 2: Performance Testing Performance data of gloves based on animal studies, biocompatibility studies i) Skin irritation in rabbits, Guinea pig sensitization (Buehler) and acute systemic cytotoxicity test were conducted on Lienteh Technology Sdn Bhd's final and finished Powder Free Blue Nitrile Examination Gloves.

Test	Performance Testing- Animal Studies- essential principles	Acceptance Criteria	Powder Free Blue Nitrile Examination Gloves Results
I. Guinea Pig Sensitization	This test was designed to determine if the test article is a potential sensitizer to guinea pigs when applied atopically.	No deviations were noted, observed nor require clarification.	No reaction was observed upon removal of the test material and there was no positive allergic reaction observed on the test of guinea pigs during the challenge phase. None of the
				guinea pigs was
sensitized.
Conclusion: meets
conformance
requirements
II.	Primary
Dermal
Irritation in
Rabbits	This test was
designed to
identify substances
which are primary
irritants to rabbit
skin	No deviations were
noted, observe nor
require
clarification.	Each test was
individually examined
and scored at $24 \pm 2$ ,
$48 \pm 2$ and $72 \pm 2$
hours for erythema
and edema using the
Draize skin scoring
scale. Results obtained
as Primary Irritation
Index was 0.
Conclusion: meets
conformance
requirements.
III.	Acute
Systemic
Cytotoxicity
in Rats	This test was
designed to
identify any
adverse biological
reaction following
administration of
the extracts of the
test item on the
rats.	No adverse
reaction was noted,
observed nor
require
clarification.	For the 4 days
observation done on
the test subject by
doing:

Cage- side
observation-
all animals
survived and
appeared
healthy and
active through
out of 4 days.
Body weight-
all animals
gained body |
| | | | | |
| | | | out of the 4
days.
Pathology- At
sacrifice times,
gross
necropsies
showed no
abnormalities
for any of the
animals.
Conclusion: meets
conformance
requirements. | |
| | | | Conclusion:
meets
conformance
requirements. | |
| ASTM D5151-19 | Pinhole Test | Free from holes,
AQL 1.5 | Pass | |
| ASTM D6319-19 | Physical Properties | Before Aging
Tensile Strength:
Min 14 MPa
Elongation: Min
500%

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Image /page/7/Picture/0 description: The image features a logo for a company called "LIENTEH TECHNOLOGY". The logo consists of a blue semi-circle at the top, with a white hand graphic inside. Below the semi-circle is a red curved line, and below that is the company name in a stylized font, with the word "TECHNOLOGY" appearing in smaller letters below "LIENTEH".

LIENTEH TECHNOLOGY SDNBHD

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Image /page/8/Picture/0 description: The image contains the logo for Lienteh Technology SDNBHD. The logo features the company name in a bold, sans-serif font, with the word "LIENTEH" in a larger font size than "TECHNOLOGY SDNBHD". To the left of the company name is a circular graphic with a stylized image of a hand reaching upwards. Below the main logo is a smaller version of the logo with the word "LIENTEH" and the word "TECHNOLOGY".

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Image /page/9/Picture/0 description: The image shows the logo for Lienteh Technology SDNBHD. The logo features the company name in bold, black font. To the left of the name is a blue and red circular graphic with the company name written below in a smaller font.

Performance data of gloves based on ASTM D6319-19 and FDA Watertight Test

| Test | ASTM D6319-19
Standard Requirement | Powder Free Blue
Nitrile Examination
Gloves |
|---------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------|
| 1. Watertight (1000mL) in
accordance with ASTM
D5151-19 | Single Sampling in
accordance with ISO 2859
G1: AQL 2.5 | Pass G1: AQL 2.5 |
| 2. Length (mm)
Size S | Min 220 | 240mm minimum
for all sizes |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 3. Palm width (mm)
Size S | $80 \pm 10$ | 84 – 86 |
| M | $95 \pm 10$ | 95-96 |
| L | $110 \pm 10$ | 108 – 109 |
| XL | $120 \pm 10$ | 114 - 115 |
| 4. Thickness (mm)
Single Layer | | |
| Finger | Min 0.05 | Min 0.06 |
| Palm | Min 0.05 | Min 0.06 |
| Cuff | Min 0.05 | Min 0.05 |
| 5. Physical Properties in
accordance with ASTM
D412-16 | | |
| 6.
Before Aging
Tensile Strength (MPa) | Min 14 | 17 – 23 |
| Ultimate Elongation (%) | Min 500 | 540 – 607 |
| After Aging
Tensile Strength (MPa) | Min 14 | 21 – 27 |
| Ultimate Elongation (%) | Min 400 | 480 - 565 |
| 7. Powder Content in
accordance with ASTM
D6124-06 | Max 2.0 mg/ glove | Below 2.0 mg/ glove |

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The performance data of the glove as shown above meet ASTM D6319-19 the standards powder requirement of residual content below 2.0 mg per glove.
. The performance data above shows that Powder Free Blue Nitrile Examination Gloves meet- ASTM D6319-19 requirement of dimensions and tolerances. Data of actual test report is attached.
. The performance data above shows that Lienteh Technology Sdn Bhd's Powder Free Blue Nitrile Examination Gloves meet- ASTM D6319-19 requirements of properties tested in accordance with ASTM D412-16. Data of actual test report is attached.

7) Discussion of Non-clinical and Performance Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

a) ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for Irritation and Skin Sensitization.
b) ISO 10993-11- Biological Evaluation of Medical devices- Part 11: Tests for Systemic toxicity.
c) ASTM D6124-06 (Reapproved 2017), Standard test method for Residual powder on medical gloves.
d) ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
e) ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

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Image /page/11/Picture/0 description: The image shows the logo for Lienteh Technology SDNBHD. The logo features a blue circle with a white hand reaching upwards, and the company name is written in bold, black letters. The word "LIENTEH" is also written in smaller letters below the circle.

Clinical Test Conclusion 8)

No clinical study is included in this submission.

9) Conclusion

The conclusion drawn from the non-clinical tests demonstrate that the subject device is safe, as effective, and perform as well as or better than the legally marketed predicated K172930.