Powder Free Blue Nitrile Examination Gloves

K213678 · Lienteh Technology Sdn Bhd · LZA · Mar 22, 2022 · General Hospital

Device Facts

• Record ID: K213678
• Device Name: Powder Free Blue Nitrile Examination Gloves
• Applicant: Lienteh Technology Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Mar 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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.

Device Story

Disposable synthetic nitrile rubber examination glove; worn on examiner's hand to provide barrier protection against contamination between patient and examiner. Device is non-sterile; blue color; powder-free. Manufactured to conform to ASTM D6319-19 standards for tensile strength, elongation, and dimensions. Used in clinical settings by healthcare professionals. Provides physical barrier to prevent cross-contamination; benefits patient and examiner by reducing exposure to contaminants.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319-19 (physical properties, dimensions), ASTM D5151-19 (watertight/pinhole test), and ASTM D6124-06 (residual powder). Biocompatibility confirmed via ISO 10993-10 (skin irritation, sensitization) and ISO 10993-11 (systemic toxicity) in animal models.

Technological Characteristics

Material: Synthetic nitrile rubber. Form factor: Disposable, non-sterile, blue, powder-free glove. Standards: ASTM D6319-19 (specifications), ASTM D5151-19 (pinhole), ASTM D6124-06 (residual powder), ASTM D412-16 (tensile properties). Thickness: 0.06-0.10 mm (finger). No software or electronic components.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. No specific patient population, age, or gender restrictions are noted.

Regulatory Classification

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.

Predicate Devices

• Mercator Medical (Thailand) LTD's mCare Powder Free Nitrile Blue Examination Gloves (K172930)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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

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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<br>Lot 6483 Jalan Sg Puloh, KU5 Kawasan Perindustrian,<br>Lorong Sungai Puloh, 42100 Klang, Selangor. |
| Contact Person | : Mohd Irsyad (Regulatory Affairs cum Senior QA Engineer)<br>Lot 6483 Jalan Sg Puloh, KU5 Kawasan Perindustrian,<br>Lorong Sungai Puloh, 42100 Klang, Selangor. |

E-mail: [e-mail]

Tel: [phone]

#### 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<br>Sdn Bhd's Powder Free<br>Blue Nitrile<br>Examination Gloves | Mercator Medical<br>(Thailand) LTD's<br>mCare Powder Free<br>Nitrile Blue<br>Examination Gloves - | |
| 510K Number | K213678 | K172930 | |
| Indications for Use | Powder Free Blue Nitrile<br>Examination Gloves are<br>disposable device intended<br>for medical purposes that<br>are worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner. | The device is a<br>disposable device<br>intended for medical<br>purposes that are worn<br>on the examiner's hand<br>to prevent<br>contamination between<br>patient and examiner. | Same |
| Design Specification | Meet ASTM D6319-19 | Meet ASTM D6319-19 | Same |
| Performance<br>Physical Properties | Meet ASTM D6319-19 | Meet ASTM D6319-19 | Same |
| Material of<br>Composition | Synthetic Nitrile<br>Rubber | Synthetic Nitrile<br>Rubber | Same |
| Biocompatibility:<br>Animal Irritation<br>Test Rabbit | Under the condition of<br>study, not an irritant | Under the condition of<br>study, not an irritant | Same |
| Dermal Sensitization<br>Test- Guinea Pig | Under the condition of<br>study, not a sensitizer | Under the condition of<br>study, not a sensitizer | Same |
| Acute Systemic<br>Cytotoxicity | Under the condition of<br>the study, no adverse<br>biological reaction | Under the condition of<br>the study, no adverse<br>biological reaction | Same |
| Color | Synthetic gloves with<br>embedded colorant-<br>Blue | Synthetic gloves with<br>embedded colorant-<br>Blue | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Powder Free | Meets applicable<br>definition for Powder<br>free; ≤ 2mg per glove | Meets applicable<br>definition for Powder<br>free; ≤ 2mg per glove | Same |
| Labelling<br>Information | Single Use indication,<br>Powder free, device<br>name, gloves size,<br>quantity, Patient<br>examination gloves,<br>Non-sterile | Single Use indication,<br>Powder free, device<br>name, gloves size,<br>quantity, Patient<br>examination gloves,<br>Non-sterile | Same |
| Physical Properties<br>as per ASTM<br>D6319-19 | Before Aging<br>Tensile Strength<br>Min 14 MPa<br>Ultimate Elongation<br>Min 500% | Before Aging<br>Tensile Strength<br>Min 14 MPa<br>Ultimate Elongation<br>Min 500% | Same |
| | After Aging<br>Tensile Strength<br>Min 14 MPa<br>Ultimate Elongation<br>Min 400% | After Aging<br>Tensile Strength<br>Min 14 MPa<br>Ultimate Elongation<br>Min 400% | |
| Dimension as per<br>ASTM D6319-19 | Finger Thickness:<br>0.06 - 0.10 mm<br>Length: min 230 mm | Finger Thickness:<br>Min 0.05 mm<br>Length: min 230 mm | Similar |
| Freedom from holes | AQL per CFR<br>21.800.20<br>Test as per ASTM<br>D5151-19 | AQL per CFR<br>21.800.20<br>Test as per ASTM<br>D5151-19 | Same |
| Residual Powder | Tested to ASTM D6124<br>and meets requirement | Tested to ASTM D6124<br>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<br>sensitized.<br>Conclusion: meets<br>conformance<br>requirements |
| II. | Primary<br>Dermal<br>Irritation in<br>Rabbits | This test was<br>designed to<br>identify substances<br>which are primary<br>irritants to rabbit<br>skin | No deviations were<br>noted, observe nor<br>require<br>clarification. | Each test was<br>individually examined<br>and scored at $24 \pm 2$ ,<br>$48 \pm 2$ and $72 \pm 2$<br>hours for erythema<br>and edema using the<br>Draize skin scoring<br>scale. Results obtained<br>as Primary Irritation<br>Index was 0.<br>Conclusion: meets<br>conformance<br>requirements. |
| III. | Acute<br>Systemic<br>Cytotoxicity<br>in Rats | This test was<br>designed to<br>identify any<br>adverse biological<br>reaction following<br>administration of<br>the extracts of the<br>test item on the<br>rats. | No adverse<br>reaction was noted,<br>observed nor<br>require<br>clarification. | For the 4 days<br>observation done on<br>the test subject by<br>doing:<br>1) Cage- side<br>observation-<br>all animals<br>survived and<br>appeared<br>healthy and<br>active through<br>out of 4 days.<br>2) Body weight-<br>all animals<br>gained body |
| | | | | |
| | | | out of the 4<br>days.<br>3) Pathology- At<br>sacrifice times,<br>gross<br>necropsies<br>showed no<br>abnormalities<br>for any of the<br>animals.<br>Conclusion: meets<br>conformance<br>requirements. | |
| | | | Conclusion:<br>meets<br>conformance<br>requirements. | |
| ASTM D5151-19 | Pinhole Test | Free from holes,<br>AQL 1.5 | Pass | |
| ASTM D6319-19 | Physical Properties | Before Aging<br>Tensile Strength:<br>Min 14 MPa<br>Elongation: Min<br>500%<br><br>After Aging<br>Tensile Strength:<br>Min 14 MPa<br>Elongation: Min<br>400% | Pass | |
| ASTM D6124-06 | Powder Residue | 2 mg/glove<br>maximum | 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 D6319-19<br>Standard Requirement | Powder Free Blue<br>Nitrile Examination<br>Gloves |
|---------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------|
| 1. Watertight (1000mL) in<br>accordance with ASTM<br>D5151-19 | Single Sampling in<br>accordance with ISO 2859<br><b>G1: AQL 2.5</b> | Pass G1: AQL 2.5 |
| 2. Length (mm)<br>Size S | Min 220 | 240mm minimum<br>for all sizes |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 3. Palm width (mm)<br>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)<br>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<br>accordance with ASTM<br>D412-16 | | |
| 6.<br><b>Before Aging</b><br>Tensile Strength (MPa) | Min 14 | 17 – 23 |
| Ultimate Elongation (%) | Min 500 | 540 – 607 |
| <b>After Aging</b><br>Tensile Strength (MPa) | Min 14 | 21 – 27 |
| Ultimate Elongation (%) | Min 400 | 480 - 565 |
| 7. Powder Content in<br>accordance with ASTM<br>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.