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.

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for "Powder Free Blue Nitrile Examination Gloves." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for an AI/ML-driven medical device. Therefore, much of the requested information regarding AI/ML device performance and testing (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, effect size of human reader improvement with AI assistance) is not applicable to this document.

However, the document does contain information about performance testing for the physical and biological properties of the gloves, which can be interpreted as "acceptance criteria" and "reported device performance."

Here's the information extracted from the document that is relevant to "acceptance criteria" and "study that proves the device meets the acceptance criteria" for these physical and biological properties:

1. A table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing:
Guinea Pig Sensitization	No deviations noted, observed, nor requiring clarification. Product is not a sensitizer.	No reaction/positive allergic reaction observed. Conforms to requirements.
Primary Dermal Irritation in Rabbits	No deviations noted, observed, nor requiring clarification. Product is not a primary irritant. Primary Irritation Index (PII) of 0.	PII was 0. Conforms to requirements.
Acute Systemic Cytotoxicity in Rats	No adverse reaction noted, observed, nor requiring clarification. No adverse biological reaction.	All animals survived, healthy, active, gained weight. No abnormalities in gross necropsies. Conforms to requirements.
Physical Properties Testing (ASTM D6319-19, D5151-19, D6124-06):
Watertight (Pinhole Test) per ASTM D5151-19	Free from holes, AQL 1.5 (G1: AQL 2.5 for 1000mL test)	Pass (G1: AQL 2.5 for 1000mL test)
Length (mm)	Size S: Min 220; M, L, XL: Min 230	240mm minimum for all sizes
Palm Width (mm)	Size S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10	S: 84-86; M: 95-96; L: 108-109; XL: 114-115
Thickness (mm) - Single Layer	Finger: Min 0.05; Palm: Min 0.05; Cuff: Min 0.05	Finger: Min 0.06; Palm: Min 0.06; Cuff: Min 0.05
Tensile Strength (MPa) - Before Aging	Min 14	17-23
Ultimate Elongation (%) - Before Aging	Min 500	540-607
Tensile Strength (MPa) - After Aging	Min 14	21-27
Ultimate Elongation (%) - After Aging	Min 400	480-565
Powder Content per ASTM D6124-06	Max 2.0 mg/glove	Below 2.0 mg/glove

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves for watertightness, physical properties, or number of animals for biocompatibility). It references ASTM and ISO standards, which would define the required sample sizes for such tests.
Data Provenance: Not explicitly stated, but the tests were performed on the "proposed device" (Powder Free Blue Nitrile Examination Gloves manufactured by Lienteh Technology Sdn Bhd in Malaysia). The tests are described as non-clinical "performance data of gloves based on animal studies, biocompatibility studies" and "performance data of gloves based on ASTM D6319-19 and FDA Watertight Test." This implies prospective laboratory testing of the manufactured product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is not an AI/ML device relying on human expert annotation for ground truth. The "ground truth" for the physical and biological properties is established by the specified ASTM/ISO standard testing methodologies and their defined criteria.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. This document does not describe a study requiring human adjudication for test results; the outcomes are based on standardized laboratory measurements and observations according to specific protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This device is an examination glove, not an AI/ML diagnostic aid influencing human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an AI algorithm. The performance described is the standalone performance of the physical glove itself.

7. The type of ground truth used:

The "ground truth" is based on standardized testing protocols and criteria defined by:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (Reapproved 2017), (Standard test method for Residual powder on medical gloves)
- ASTM D412-16 (for physical properties like tensile strength and elongation)
- 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)
- FDA watertight test AQL criteria (21 CFR 800.20)

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable. As above, it's not an AI/ML device.

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

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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

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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.

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

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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 BhdLot 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

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 TechnologySdn Bhd's Powder FreeBlue NitrileExamination Gloves	Mercator Medical(Thailand) LTD'smCare Powder FreeNitrile BlueExamination Gloves -
510K Number	K213678	K172930
Indications for Use	Powder Free Blue NitrileExamination Gloves aredisposable device intendedfor medical purposes thatare worn on theexaminer's hand to preventcontamination betweenpatient and examiner.	The device is adisposable deviceintended for medicalpurposes that are wornon the examiner's handto preventcontamination betweenpatient and examiner.	Same
Design Specification	Meet ASTM D6319-19	Meet ASTM D6319-19	Same
PerformancePhysical Properties	Meet ASTM D6319-19	Meet ASTM D6319-19	Same
Material ofComposition	Synthetic NitrileRubber	Synthetic NitrileRubber	Same
Biocompatibility:Animal IrritationTest Rabbit	Under the condition ofstudy, not an irritant	Under the condition ofstudy, not an irritant	Same
Dermal SensitizationTest- Guinea Pig	Under the condition ofstudy, not a sensitizer	Under the condition ofstudy, not a sensitizer	Same
Acute SystemicCytotoxicity	Under the condition ofthe study, no adversebiological reaction	Under the condition ofthe study, no adversebiological reaction	Same
Color	Synthetic gloves withembedded colorant-Blue	Synthetic gloves withembedded colorant-Blue	Same
Sterility	Non-Sterile	Non-Sterile	Same
Powder Free	Meets applicabledefinition for Powderfree; ≤ 2mg per glove	Meets applicabledefinition for Powderfree; ≤ 2mg per glove	Same
LabellingInformation	Single Use indication,Powder free, devicename, gloves size,quantity, Patientexamination gloves,Non-sterile	Single Use indication,Powder free, devicename, gloves size,quantity, Patientexamination gloves,Non-sterile	Same
Physical Propertiesas per ASTMD6319-19	Before AgingTensile StrengthMin 14 MPaUltimate ElongationMin 500%	Before AgingTensile StrengthMin 14 MPaUltimate ElongationMin 500%	Same
	After AgingTensile StrengthMin 14 MPaUltimate ElongationMin 400%	After AgingTensile StrengthMin 14 MPaUltimate ElongationMin 400%
Dimension as perASTM D6319-19	Finger Thickness:0.06 - 0.10 mmLength: min 230 mm	Finger Thickness:Min 0.05 mmLength: min 230 mm	Similar
Freedom from holes	AQL per CFR21.800.20Test as per ASTMD5151-19	AQL per CFR21.800.20Test as per ASTMD5151-19	Same
Residual Powder	Tested to ASTM D6124and meets requirement	Tested to ASTM D6124and 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 wassensitized.Conclusion: meetsconformancerequirements
II.	PrimaryDermalIrritation inRabbits	This test wasdesigned toidentify substanceswhich are primaryirritants to rabbitskin	No deviations werenoted, observe norrequireclarification.	Each test wasindividually examinedand scored at $24 \pm 2$ ,$48 \pm 2$ and $72 \pm 2$hours for erythemaand edema using theDraize skin scoringscale. Results obtainedas Primary IrritationIndex was 0.Conclusion: meetsconformancerequirements.
III.	AcuteSystemicCytotoxicityin Rats	This test wasdesigned toidentify anyadverse biologicalreaction followingadministration ofthe extracts of thetest item on therats.	No adversereaction was noted,observed norrequireclarification.	For the 4 daysobservation done onthe test subject bydoing:1) Cage- sideobservation-all animalssurvived andappearedhealthy andactive throughout of 4 days.2) Body weight-all animalsgained body

			out of the 4days.3) Pathology- Atsacrifice times,grossnecropsiesshowed noabnormalitiesfor any of theanimals.Conclusion: meetsconformancerequirements.
			Conclusion:meetsconformancerequirements.
ASTM D5151-19	Pinhole Test	Free from holes,AQL 1.5	Pass
ASTM D6319-19	Physical Properties	Before AgingTensile Strength:Min 14 MPaElongation: Min500%After AgingTensile Strength:Min 14 MPaElongation: Min400%	Pass
ASTM D6124-06	Powder Residue	2 mg/glovemaximum	Pass

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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 D6319-19Standard Requirement	Powder Free BlueNitrile ExaminationGloves
1. Watertight (1000mL) inaccordance with ASTMD5151-19	Single Sampling inaccordance with ISO 2859G1: AQL 2.5	Pass G1: AQL 2.5
2. Length (mm)Size S	Min 220	240mm minimumfor 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 inaccordance with ASTMD412-16
6.Before AgingTensile Strength (MPa)	Min 14	17 – 23
Ultimate Elongation (%)	Min 500	540 – 607
After AgingTensile Strength (MPa)	Min 14	21 – 27
Ultimate Elongation (%)	Min 400	480 - 565
7. Powder Content inaccordance with ASTMD6124-06	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.

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.