Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile

K221378 · Tec Gloves Industry (M) Sdn.Bhd. · LZA · Sep 30, 2022 · General Hospital

Device Facts

• Record ID: K221378
• Device Name: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
• Applicant: Tec Gloves Industry (M) Sdn.Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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

Device Story

Nitrile powder-free blue patient examination gloves; disposable; ambidextrous; single-use. Manufactured from acrylonitrile-butadiene copolymer dispersion. Surface treatment produces smooth finish for easy donning without powder. Available in six sizes (XS-XXL). Used in clinical settings by healthcare examiners to provide barrier protection against contamination. Physical properties meet ASTM D6319-19 standards. Device is non-sterile.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via ASTM D6124-06 (residual powder), ASTM D5151-19 (freedom from holes), and ASTM D6319-19 (physical dimensions and tensile properties). Biocompatibility testing performed per ISO 10993-10 (irritation and sensitization) and ISO 10993-11 (acute systemic toxicity). All tests met acceptance criteria.

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer. Form: Ambidextrous, blue, powder-free, finger-textured. Dimensions: Average length 245mm, palm thickness 0.06mm, finger thickness 0.09mm. Standards: ASTM D6319-19 (physical properties/dimensions), ASTM D5151-19 (holes), ASTM D6124-06 (residual powder), ISO 10993 (biocompatibility). Non-sterile.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

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

• Nitrile Powder Free Blue Patient Examination Gloves, Non-sterile (K210369)

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). 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

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

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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) 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.

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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/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

[phone] ए www.tecgloves.com

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: [e-mail] Tel: [phone] 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

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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 [phone] 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.

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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

> [phone] ए www.tecgloves.com ക

| able<br>- | 1 |
|-----------|---|
|-----------|---|

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

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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

> [phone] ए www.tecgloves.com

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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

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

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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

> [phone] ए www.tecgloves.com

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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

> [phone] www.tecgloves.com

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

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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

> [phone] 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.