Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)

K211457 · Ammex Corporation · LZA · Dec 18, 2021 · General Hospital

Device Facts

• Record ID: K211457
• Device Name: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
• Applicant: Ammex Corporation
• Product Code: LZA · General Hospital
• Decision Date: Dec 18, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; worn on examiner's hands; prevents cross-contamination between patient and examiner. Available in blue, black, and indigo colors; various sizes (XS-XL). Manufactured from acrylonitrile-butadiene; powder-free; ambidextrous; finger-textured. Used in clinical settings by healthcare professionals. Performance verified against ASTM D6319 standards for tensile strength, elongation, and pinhole AQL. Biocompatibility confirmed via ISO 10993 testing (irritation, sensitization, cytotoxicity).

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319 (tensile strength, elongation), ASTM D6124 (residual powder), and ASTM D5151 (pinhole detection). Biocompatibility verified via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Material: Nitrile (Acrylonitrile-butadiene). Surface: Powder-free, finger-textured. Form factor: Ambidextrous, various sizes (XS-XL). Standards: ASTM D6319, ASTM D6124, ASTM D5151, ISO 10993. Energy source: None (manual). Connectivity: None.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands to prevent contamination between patient and examiner. Suitable for use by clinicians in medical settings.

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

• Powder Free Nitrile Gloves (White, Cobalt Blue, Black, Ice Blue) (K150340)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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.

December 18, 2021

Ammex Corporation Davendran Tangaya Manager of Compliance & Product Development 1019 W James St. Suite 200 Kent, Washington 98032

Re: K211457

Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 20, 2021 Received: November 26, 2021

Dear Davendran Tangaya:

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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# Indications for Use

510(k) Number (if known) K211457

#### Device Name

Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)

Indications for Use (Describe)

The Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a disposable device intended for medical purpose that is worn on the examiner's hands 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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Image /page/3/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, green letters, with a blue line underneath. To the right of the word is a blue gear symbol.

# 510(k) Summary

The assigned 510(k) Number: K211457

1. Date of Preparation: 16 Dec 2021

- 2. Sponsor
Ammex Corporation 1019 W James St #200, Kent, WA 98032, United States Contact Person: Sasitharan Nair Position: Senior VP of Global Sourcing and Product Innovation Tel: + 425-251-4000 Fax: + 425-251-4621 Email: snair(@ammex.com

3. Submission Correspondent

# Ammex Corporation

1019 W James St #200, Kent, WA 98032, United States Contact Person: Davendran Position: Manager of Compliance & Product Development Tel: + 425-251-4000 Fax: + 425-251-4621 Email: [e-mail]

4. Proposed Device Identification

Trade Name: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) Common Name: Nitrile Patient Examination Gloves (Powder Free)

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Image /page/4/Picture/0 description: The image contains the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters. Below the word is the text "Malaysia SDN BHD" in a smaller font. To the right of the word is a blue gear symbol.

Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Product Name: Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)

Indication for Use Statement:

The Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.

5. Predicate Device Identification 510(k) Number: K150340 Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Product Name: Powder Free Nitrile Gloves (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD

6. Device Description

The proposed device, Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

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Image /page/5/Picture/0 description: The image contains the logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, bold, green letters. Below the word is the text "Malaysia SDN BHD" in smaller, blue letters. To the right of the word is a blue gear.

The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Black, and Indigo. Product Reference Number: APFN4X100 (Blue) Product Reference Number: ABNPF4X100 (Black) Product Reference Number: AINPF4X100 (Indigo)

7. Technological Characteristics Comparison with predicate device (Blue)

#### A. Powder Free Nitrile Examination Gloves - Blue

| Size | Length (mm) | Width (mm) | Thickness (mm) | | | |
|-------------|--------------|-----------------|--------------------------|------------------------|------------------------|--|
| Extra Small | $\u2265 230$ | 75 \u00b1 5 mm | Finger<br>0.10\u00b10.02 | Palm<br>0.08\u00b10.02 | Cuff<br>0.06\u00b10.02 | |
| Small | | 85 \u00b1 5 mm | | | | |
| Medium | | 95 \u00b1 5 mm | | | | |
| Large | | 105 \u00b1 5 mm | | | | |
| Extra Large | | 115 \u00b1 5 mm | | | | |
| Color | Blue | | | | | |

# Table 1: Device Size Specifications

## Table 2: Performance and Physical Specifications (For XS, S, M, L, XL)

| Property | Unit | Conditioning | Specification | Pinhole AQL |
|---------------------|------|--------------|---------------|-------------|
| Tensile Strength | MPa | Unaged | $\ge 14$ | $\le 2.5$ |
| Elongation at Break | % | | $\ge 500$ | |
| Tensile Strength | MPa | Aged | $\ge 14$ | |
| Elongation at Break | % | | $\ge 400$ | |

Discussion: The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319

| Characteristics and<br>Parameters | Proposed Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(Blue) | Predicate Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(White, Cobalt Blue,<br>Black, Ice Blue) | Comparison |
|-----------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K211457 | K150340 | Different |
| Product Code | LZA | LZA | Same |

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Image /page/6/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in bold, green letters, with the "X" stylized in a lighter green. Below the word "AMMEX" is the text "Malaysia SDN BHD" in a smaller font. To the right of the text is a blue gear graphic.

| Intended Use | The Powder Free Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Powder Free Nitrile Gloves (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | Same |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Classification | Class 1 | Class 1 | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Raw Rubber Material | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same |
| Surface Treatment / Powder or Powder Free | Powder Free | Powder Free | Same |
| Surface Appearance | 1. Ambidextrous<br>2. Finger Textured | 1. Ambidextrous<br>2. Finger Textured | Same |
| Color | Blue | White, Cobalt Blue, Black & Ice Blue | Different<br>Colors |

## Table 4: Device Dimension Comparison Table

| Proposed Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(Blue)<br>(K211457) | Designation | XS | S | M | L | XL | Tolerance |
|-------------------------------------------------------------------------------------------------------------------------|---------------|-----------|-----|-----|-----|-----|------------|
| | Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm$ 10 |
| | Thickness, mm | | | | | | |
| | Finger | 0.10-0.12 | | | | | $\pm$ 0.02 |
| | Palm | 0.08-0.10 | | | | | $\pm$ 0.02 |
| | Cuff | 0.06-0.07 | | | | | $\pm$ 0.02 |
| Predicate Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(White, Cobalt Blue,<br>Black, Ice Blue)<br>(K150340) | Designation | XS | S | M | L | XL | Tolerance |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | $\pm$ 10 |
| | Thickness, mm | | | | | | |
| | Finger | 0.10-0.12 | | | | | $\pm$ 0.03 |
| | Palm | 0.08-0.10 | | | | | $\pm$ 0.03 |
| | Cuff | 0.06-0.09 | | | | | $\pm$ 0.03 |

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Image /page/7/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters. Below the word "AMMEX" is the text "Malaysia SDN BHD" in a smaller font. To the right of the word "AMMEX" is a blue gear.

Discussion: The sizes and tolerances of proposed device are different with those of the predicate.

| Characteristics and<br>Parameters | Proposed Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(Blue)<br>(K211457) | Predicate Device:<br>Powder Free Nitrile<br>Examination<br>Gloves (White,<br>Cobalt Blue, Black,<br>Ice Blue) (K150340) | Comparison |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Tensile Strength<br>(before age)<br>Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement of<br>Tensile Strength under<br>ASTM D6319 |
| Tensile Strength (after<br>age) Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement of<br>Tensile Strength under<br>ASTM D6319 |
| Ultimate Elongation<br>(before age) Minimum<br>14 MPa | Min 500% | Min 500% | Meeting requirement of<br>elongation under ASTM<br>D6319 |
| Ultimate Elongation<br>(after age) Minimum 14<br>MPa | Min 400% | Min 400% | Meeting requirement of<br>elongation under ASTM<br>D6319 |
| Freedom of Holes Meet<br>AQL 2.5 at G1 | Meet AQL 1.5 with<br>G1 | Meet AQL 1.5 with<br>G1 | Meeting requirement of<br>freedom of holes under<br>ASTM D6319 |
| Residual powder test<br>(Less than 2mg / glove) | Average powder<br>residue for each size:<br>S: 0.30 mg/glove<br>M: 0.31 mg/glove<br>L: 0.45 mg/glove | Contained less than<br>2 mg/glove | Meeting requirement of<br>powder residue under<br>ASTM D6319 |
| Primary Skin Irritation<br>(Surface-contacting, less<br>than 24 hours<br>duration) | Under the conditions<br>of study, not an irritant | Under the conditions<br>of study, not an<br>irritant | Yes, both are tested to be<br>non-irritant |
| Dermal Sensitization<br>(Surface-contacting, less<br>than 24 hours<br>duration) | Under the conditions<br>of study, not a<br>sensitizer | Under the conditions<br>of study, not a<br>sensitizer | Yes, both are tested to be<br>non-sensitizer |
| In Vitro Cytotoxicity<br>(Surface-contacting, less<br>than 24 hours duration) | Under the conditions<br>of study, non-<br>cytotoxic | Not tested | The predicate device was<br>not tested for In Vitro<br>Cytotoxicity |
| Intracutaneous Reactivity | Under the conditions<br>of study, not an irritant | Not tested | The predicate device was<br>not tested for<br>Intracutaneous reactivity |

# Table 5: Device Performance Comparison

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Image /page/8/Picture/0 description: The image contains the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters, with a blue line underneath. To the right of the word is a blue gear symbol. Below the word "AMMEX" is the text "Malaysia SDN BHD".

Discussion: The proposed device has different color to the predicate device.

- 8. Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.

| Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Results |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10:2010<br>Biological Evaluation of Medical Devices -<br>Part 10: Tests for Irritation and Skin<br>Sensitization. | This part of ISO 10993 assesses possible<br>contact hazards from<br>chemicals released<br>from medical devices,<br>which may produce<br>skin and mucosal<br>irritation, eye irritation<br>or skin sensitization. | Skin Sensitization Test:<br>Provided gradesLess than 1.0 (<1.0),<br>otherwise sensitization.<br>0- No visible change<br>1- Discrete erythema<br>2- Moderate erythema<br>3- Intense erythema<br><br>Scoring: Less than 1.0 (<1.0), no erythema /oedema. Since the<br>scoring is less than 1, the response category is<br>negligible.<br>0- No erythema /oedema<br>1- Slight erythema /oedema<br>2- Well defined erythema /oedema | Under the conditions of this<br>study, the gloves showed no<br>evidence of causing skin<br>contact sensitization.<br><br>Under the condition of this<br>study, there was no erythema/<br>edema. The gloves are<br>considered non-irritant. |
| | | 3- Moderate erythema<br>/oedema<br>4- Severe erythema<br>/oedema | |
| ISO 10993-5:2009<br>Biological Evaluation<br>Of<br>Medical Devices -<br>Part<br>5: Tests For In Vitro<br>Cytotoxicity | This part of ISO<br>10993 describes test<br>methods to assess the<br>in vitro cytotoxicity of<br>medical devices. | For biocompatible, if<br>the number of viable<br>L929 mouse fibroblasts<br>counts in direct method<br>should be more than<br>70% to pass the test. | The study finds that the cells<br>beneath the test samples<br>incubated for 72 hours did not<br>show any signs of<br>cytotoxicity. The glove is<br>non-cytotoxic to L-292 cell<br>lines. |
| ISO 10993-10: 2010<br>Biological Evaluation<br>of Medical Devices-<br>Test for Irritation and<br>Skin Sensitization-<br>part<br>10: Tests for<br>Intracutaneous<br>Reactivity | The test article<br>identified below was<br>evaluated for<br>intracutaneous<br>reactivity potential on<br>single topical<br>application. | The requirements of the<br>test were met if the<br>difference between the<br>test extract mean score<br>and control mean score<br>was 1.0 or less.<br>0-No erythema<br>/oedema<br>1-Slight erythema<br>/oedema<br>2-Well defined<br>erythema /oedema<br>3-Moderate erythema<br>/oedema<br>4- Severe erythema<br>/oedema | Under the conditions of this<br>study, there was no erythema<br>and no edema. The glove is<br>considered a non- irritant. |
| ASTM D6124-06<br>(Reapproved 2017),<br>Standard Test Method<br>for Residual Powder<br>on Medical Gloves | This standard is<br>designed to determine<br>the amount of residual<br>powder (or filter-<br>retained mass) found<br>on medical gloves. | Powder residue limit of<br>2.0 mg | Requirement met. |
| ASTM D5151 06<br>(Reapproved 2015),<br>Standard Test Method<br>for Detection of Holes<br>in Medical Gloves. | This test method<br>covers the detection<br>of holes in medical<br>gloves. | Samples number: 500<br>gloves<br>AQL: 2.5 (ISO 2859)<br>Criterion ≤ 21 gloves<br>for water leakage | Requirement met. |

Table 6: Summary of Non-Clinical Performance Testing

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Image /page/9/Picture/0 description: The image is a logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, bold, green letters. Below the word "AMMEX" is the phrase "Malaysia SDN BHD" in smaller, blue letters. To the right of the word "AMMEX" is a blue gear.

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Image /page/10/Picture/0 description: The image is a logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters. Below the word "AMMEX" is the text "Malaysia SDN BHD" in smaller, blue letters. To the right of the word "AMMEX" is a blue gear.

- 9. Summary of Clinical Performance Test
No clinical study is included in this submission.

- 10. Photograph of Powder Free Nitrile Examination Gloves (Blue)
Product Reference Number: APFN4X100

('X' on the Product Reference Number denotes the size of the glove, please refer Attachment 15)

Image /page/10/Picture/7 description: The image shows a blue, disposable glove. The glove is laid flat on a white surface. The glove is wrinkled and has five fingers.

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Image /page/11/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters, with the "X" stylized to incorporate a blue gear shape. Below the word "AMMEX" is the text "Malaysia SDN BHD" in a smaller font. The image also contains the text "11. Conclusion".

The conclusions drawn from the nonclinical tests demonstrate that the proposed device, (K211457: Powder Free Nitrile Examination Gloves, in Blue is as safe, as effective, and performs as well as or better than the legally marketed predicated device, (K150340: Powder Free Nitrile Examination Gloves in White, Cobalt Blue, Black, and Ice Blue.

## 12. Summary comparing technological characteristics with predicate device (Black)

#### B. Powder Free Nitrile Examination Gloves – Black

| Size | Length (mm) | Width (mm) | Thickness (mm) | | | |
|-------------|-------------|------------|---------------------|-------------------|-------------------|--|
| Extra Small | ≥ 230 | 75 ± 5 mm | Finger<br>0.10±0.02 | Palm<br>0.08±0.02 | Cuff<br>0.06±0.02 | |
| Small | | 85 ± 5 mm | | | | |
| Medium | | 95 ± 5 mm | | | | |
| Large | | 105 ± 5 mm | | | | |
| Extra Large | | 115 ± 5 mm | | | | |
| Color | Black | | | | | |

#### Table 7: Device Size Specifications

# Table 8: Performance and Physical Specifications (For XS, S, M, L, XL)

| Property | Unit | Conditioning | Specification | Pinhole AQL |
|---------------------|------|--------------|---------------|-------------|
| Tensile Strength | MPa | Unaged | $\ge 14$ | $\le 2.5$ |
| Elongation at Break | % | | $\ge 500$ | |
| Tensile Strength | MPa | Aged | $\ge 14$ | |
| Elongation at Break | % | | $\ge 400$ | |

Discussion: The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319

13. Technological Characteristic Comparison

| Characteristics and<br>Parameters | Proposed Device: Powder<br>Free Nitrile Examination<br>Gloves (Black) | Predicate Device: Powder<br>Free Nitrile Examination<br>Gloves (White, Cobalt<br>Blue, Black, Ice Blue) | Comparison |
|-----------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K211457 | K150340 | Different |
| Product Code | LZA | LZA | Same |

#### Table 9: Device General Comparison Table

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Image /page/12/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in bold, green letters, with a blue line underneath. Below the line, the words "Malaysia SDN BHD" are written in a smaller font. To the right of the word "AMMEX" is a blue gear symbol.

| Intended Use | The Powder Free Nitrile<br>Examination Gloves is a<br>disposable device intended<br>for medical purpose that is<br>worn on the examiner's<br>hands to prevent<br>contamination between<br>patient and examiner. | The Powder Free Nitrile<br>Gloves (White, Cobalt Blue,<br>Black, Ice Blue) is a<br>disposable device intended<br>for medical<br>purposes that is worn on the<br>examiner's hands to prevent<br>contamination between<br>patient and examiner. | Same |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Classification | Class 1 | Class 1 | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Raw Rubber Material | Nitrile (Acrylonitrile-<br>butadiene) | Nitrile (Acrylonitrile-<br>butadiene) | Same |
| Surface Treatment /<br>Powder or Powder Free | Powder Free | Powder Free | Same |
| Surface Appearance | 3. Ambidextrous<br>4. Finger Textured | 3. Ambidextrous<br>4. Finger Textured | Same |
| Color | Black | White, Cobalt Blue, Black &<br>Ice Blue | Different Colors |

# Table 10: Device Dimension Comparison Table

| Proposed Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(Black)<br>(K211457) | Designation | XS | S | M | L | XL | Tolerance | Characteristics and<br>Parameters | Proposed Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(Black)<br>(K211457) | Predicate Device:<br>Powder Free Nitrile<br>Examination<br>Gloves (White,<br>Cobalt Blue, Black,<br>Ice Blue) (K150340) | Comparison |
|-------------------------------------------------------------------------------------------------------------------------|---------------|-----------|-----|-----|-----|-----|-----------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum | Tensile Strength<br>(before age)<br>Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement of<br>Tensile Strength under<br>ASTM D6319 |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | ± 10 | Tensile Strength (after<br>age) Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement of<br>Tensile Strength under<br>ASTM D6319 |
| | Thickness, mm | | | | | | | Ultimate Elongation<br>(before age) Minimum<br>14 MPa | Min 500% | Min 500% | Meeting requirement of<br>elongation under ASTM<br>D6319 |
| | Finger | 0.10-0.12 | | | | | ±0.02 | Ultimate Elongation<br>(after age) Minimum 14<br>MPa | Min 400% | Min 400% | Meeting requirement of<br>elongation under ASTM<br>D6319 |
| | Palm | 0.08-0.10 | | | | | ±0.02 | Freedom of Holes Meet<br>AQL 2.5 at G1 | Meet AQL 1.5 with<br>G1 | Meet AQL 1.5 with<br>G1 | Meeting requirement of<br>freedom of holes under<br>ASTM D6319 |
| | Cuff | 0.06-0.07 | | | | | ±0.02 | Residual powder test<br>(Less than 2mg / glove) | Average powder<br>residue for each size:<br>S: 0.30 mg/glove<br>M: 0.31 mg/glove<br>L: 0.45 mg/glove | Contained less than<br>2 mg/glove | Meeting requirement of<br>powder residue under<br>ASTM D6319 |
| Predicate Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(White, Cobalt Blue,<br>Black, Ice Blue)<br>(K150340) | Designation | XS | S | M | L | XL | Tolerance | Primary Skin Irritation<br>(Surface-contacting, less<br>than 24 hours<br>duration) | Under the conditions<br>of study, not an irritant | Under the conditions<br>of study, not an<br>irritant | Yes, both are tested to be<br>non-irritant |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum | Dermal Sensitization<br>(Surface-contacting, less<br>than 24 hours<br>duration) | Under the conditions<br>of study, not a<br>sensitizer | Under the conditions<br>of study, not a<br>sensitizer | Yes, both are tested to be<br>non-sensitizer |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ± 10 | In Vitro Cytotoxicity<br>(Surface-contacting, less<br>than 24 hours<br>duration) | Under the conditions<br>of study, non-<br>cytotoxic | Not tested | The predicate device was<br>not tested for In Vitro<br>Cytotoxicity |
| | Thickness, mm | | | | | | | | | | |
| | Finger | 0.10-0.12 | | | | | ±0.03 | | | | |
| | Palm | 0.08-0.10 | | | | | ±0.03 | | | | |
| | Cuff | 0.06.0.09 | | | | | ±0.03 | | | | |

Discussion: The sizes and tolerances of proposed device are different with those of the predicate.

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Image /page/13/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters. Below the word "AMMEX" is the text "Malaysia SDN BHD" in a smaller font. To the right of the word "AMMEX" is a blue gear.

# Table 11: Device Performance Comparison

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Image /page/14/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, green letters. Below the word is the text "Malaysia SDN BHD" in a smaller font. To the right of the word is a blue gear.

| Intracutaneous Reactivity | Under the conditions<br>of study, not an irritant | Not tested | The predicate device was<br>not tested for<br>Intracutaneous reactivity |
|---------------------------|---------------------------------------------------|------------|-------------------------------------------------------------------------|
|---------------------------|---------------------------------------------------|------------|-------------------------------------------------------------------------|

Discussion: The proposed device has different color to the predicate device.

14. Summary of Non-Clinical Performance Testing

The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.

| Name of the Test<br>Methodology /<br>Standard | Purpose | Acceptance Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10:2010<br>Biological Evaluation<br>of Medical Devices -<br>Part 10: Tests for<br>Irritation and Skin<br>Sensitization. | This part of ISO 10993<br>assesses possible<br>contact hazards from<br>chemicals released<br>from medical devices,<br>which may produce<br>skin and mucosal<br>irritation, eye irritation<br>or skin sensitization. | Skin Sensitization Test:<br>Provided gradesLess<br>than 1.0 (<1.0),<br>otherwise sensitization.<br>0- No visible change<br>1- Discrete erythema<br>2- Moderate erythema<br>3- Intense erythema | Under the conditions of this<br>study, the gloves showed no<br>evidence of causing skin<br>contact sensitization. |
| | | Scoring: Less than 1.0<br>(<1.0), no erythema<br>/oedema. Since the<br>scoring is less than 1,<br>the response category is<br>negligible.<br>0- No erythema<br>/oedema<br>1- Slight erythema<br>/oedema<br>2- Well defined<br>erythema /oedema<br>3- Moderate erythema<br>/oedema<br>4- Severe erythema<br>/oedema | Under the condition of this<br>study, there was no erythema/<br>edema. The gloves are<br>considered non-irritant. |
| ISO 10993-5:2009<br>Biological Evaluation<br>Of<br>Medical Devices -<br>Part<br>5: Tests For In Vitro<br>Cytotoxicity | This part of ISO<br>10993 describes test<br>methods to assess the<br>in vitro cytotoxicity of<br>medical devices. | For biocompatible, if<br>the number of viable<br>L929 mouse fibroblasts<br>counts in direct method<br>should be more than<br>70% to pass the test. | The study finds that the cells<br>beneath the test samples<br>incubated for 72 hours did not<br>show any signs of<br>cytotoxicity. The glove is<br>non-cytotoxic to L-292 cell<br>lines. |
| ISO 10993-10: 2010<br>Biological Evaluation<br>of Medical Devices-<br>Test for Irritation and<br>Skin Sensitization-<br>part 10: Tests for<br>Intracutaneous<br>Reactivity | The test article<br>identified below was<br>evaluated for<br>intracutaneous<br>reactivity potential on<br>single topical<br>application. | The requirements of the<br>test were met if the<br>difference between the<br>test extract mean score<br>and control mean score<br>was 1.0 or less.<br>0-No erythema<br>/oedema<br>1-Slight erythema<br>/oedema<br>2-Well defined<br>erythema /oedema<br>3-Moderate erythema<br>/oedema<br>4- Severe erythema<br>/oedema | Under the conditions of this<br>study, there was no erythema<br>and no edema. The glove is<br>considered a non- irritant. |
| ASTM D6124-06<br>(Reapproved 2017),<br>Standard Test Method<br>for Residual Powder<br>on Medical Gloves | This standard is<br>designed to determine<br>the amount of residual<br>powder (or filter-<br>retained mass) found<br>on medical gloves. | Powder residue limit of<br>2.0 mg | Requirement met. |
| ASTM D5151 06<br>(Reapproved 2015),<br>Standard Test Method<br>for Detection of Holes<br>in Medical Gloves. | This test method<br>covers the detection<br>of holes in medical<br>gloves. | Samples number: 500<br>gloves<br>AQL: 2.5 (ISO 2859)<br>Criterion < 21 gloves<br>for water leakage | Requirement met. |

## Table 12: Summary of Non-Clinical Performance Testing

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Image /page/15/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in bold, green letters, with the "X" stylized to resemble a gear. Below the word "AMMEX" is the text "Malaysia SDN BHD" in a smaller font. The gear is blue.

# 15. Summary of Clinical Performance Test

No clinical study is included in this submission.

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Image /page/16/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, bold, green letters. Below the word is a blue line, and below the line is the text "Malaysia SDN BHD" in a smaller font. To the right of the word "AMMEX" is a blue gear.

#### 16. Photograph of Powder Free Nitrile Examination Gloves (Black)

#### Product Reference Number: ABNPF4X100

('X' on the Product Reference Number denotes the size of the glove, please refer Attachment 15)

Image /page/16/Picture/4 description: The image shows a hand wearing a black glove. The glove appears to be made of a smooth, possibly latex or nitrile material. The hand is positioned with the palm facing forward and the fingers extended. The background is a plain white surface.

#### 17. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device, (K211457: Powder Free Nitrile Examination Gloves, in Black is as safe, as effective, and performs as well as or better than the legally marketed predicated device, (K150340: Powder Free Nitrile Examination Gloves in White, Cobalt Blue, Black, and Ice Blue.

{17}------------------------------------------------

Image /page/17/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, bold, green letters. Below the word "AMMEX" is the text "Malaysia SDN BHD" in smaller, blue letters. To the right of the word "AMMEX" is a blue gear.

#### 18. Summary comparing technological characteristics with predicate device (Indigo)

#### C. Powder Free Nitrile Examination Gloves - Indigo

## Table 13: Device Size Specifications

| Size | Length (mm) | Width (mm) | Thickness (mm) | | |
|-------------|-------------|------------|---------------------|-------------------|-------------------|
| Extra Small | ≥ 230 | 75 ± 5 mm | Finger<br>0.10±0.02 | Palm<br>0.08±0.02 | Cuff<br>0.06±0.02 |
| Small | | 85 ± 5 mm | | | |
| Medium | | 95 ± 5 mm | | | |
| Large | | 105 ± 5 mm | | | |
| Extra Large | | 115 ± 5 mm | | | |
| Color | Indigo | | | | |

#### Table 14: Performance and Physical Specifications (For XS, S, M, L, XL)

| Property | Unit | Conditioning | Specification | Pinhole AQL |
|---------------------|------|--------------|---------------|-------------|
| Tensile Strength | MPa | Unaged | $\ge$ 14 | $\le$ 2.5 |
| Elongation at Break | % | | $\ge$ 500 | |
| Tensile Strength | MPa | Aged | $\ge$ 14 | |
| Elongation at Break | % | | $\ge$ 400 | |

Discussion: The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319.

#### 19. Technological Characteristics Comparison

#### Table 15: Device General Comparison Table

| Characteristics and<br>Parameters | Proposed Device: Powder<br>Free Nitrile Examination<br>Gloves (Indigo)<br>(K211457) | Predicate Device: Powder<br>Free Nitrile Examination<br>Gloves (White, Cobalt<br>Blue, Black, Ice Blue)<br>(K150340) | Comparison |
|-----------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K211457 | K150340 | Different |
| Product Code | LZA | LZA | Same |

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Image /page/18/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, green, bold letters. Underneath the word "AMMEX" is the phrase "Malaysia SDN BHD" written in smaller, dark blue letters. To the right of the text is a blue gear.

| Intended Use | The Powder Free Nitrile<br>Examination Gloves is a<br>disposable device intended<br>for medical purpose that is<br>worn on the examiner's<br>hands to prevent<br>contamination between<br>patient and examiner. | The Powder Free Nitrile<br>Gloves (White, Cobalt<br>Blue, Black, Ice Blue) is a<br>disposable device intended<br>for medical<br>purposes that are worn on<br>the examiner's hands to<br>prevent contamination<br>between patient and<br>examiner. | Same |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Classification | Class 1 | Class 1 | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Raw Rubber Material | Nitrile (Acrylonitrile-<br>butadiene) | Nitrile (Acrylonitrile-<br>butadiene) | Same |
| Surface Treatment /<br>Powder or Powder Free | Powder Free | Powder Free | Same |
| Surface Appearance | 0- Ambidextrous<br>1- Finger Textured | 5. Ambidextrous<br>6. Finger Textured | Same |
| Color | Indigo | White, Cobalt Blue, Black &<br>Ice Blue | Different Colors |

# Table 16: Device Dimension Comparison Table

| Proposed Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(Indigo)<br>(K211457) | Designation | XS | S | M | L | XL | Tolerance |
|-------------------------------------------------------------------------------------------------------------------------|---------------|-----|-----|-----------|-----|-----|-----------|
| | Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum |
| | Width, mm | 75 | 85 | 95 | 105 | 115 | ± 10 |
| | Thickness, mm | | | | | | |
| | Finger | | | 0.10-0.12 | | | ±0.02 |
| | Palm | | | 0.08-0.10 | | | ±0.02 |
| | Cuff | | | 0.06-0.07 | | | ±0.02 |
| Predicate Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(White, Cobalt Blue,<br>Black, Ice Blue)<br>(K150340) | Designation | XS | S | M | L | XL | Tolerance |
| | Length, mm | 230 | 230 | 230 | 230 | 230 | Minimum |
| | Width, mm | 70 | 80 | 95 | 110 | 120 | ± 10 |
| | Thickness, mm | | | | | | |
| | Finger | | | 0.10-0.12 | | | ±0.03 |
| | Palm | | | 0.08-0.10 | | | ±0.03 |
| | Cuff | | | 0.06.0.09 | | | ±0.03 |

Discussion: The sizes and tolerances of proposed device are different with those of the predicate.

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The word "AMMEX" is written in large, bold, green letters. Below the word is a blue line, and below the line is the text "Malaysia SDN BHD" in a smaller font. To the right of the word "AMMEX" is a blue gear.

# Table 17: Device Performance Comparison

| Characteristics and<br>Parameters | Proposed Device:<br>Powder Free Nitrile<br>Examination Gloves<br>(Indigo)<br>(K211457) | Predicate Device:<br>Powder Free Nitrile<br>Examination<br>Gloves (White,<br>Cobalt Blue, Black,<br>Ice Blue) (K150340) | Comparison |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Tensile Strength<br>(before age)<br>Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement of<br>Tensile Strength under<br>ASTM D6319 |
| Tensile Strength (after<br>age) Minimum 14 MPa | Min 14 MPa | Min 14 MPa | Meeting requirement of<br>Tensile Strength under<br>ASTM D6319 |
| Ultimate Elongation<br>(before age) Minimum<br>14 MPa | Min 500% | Min 500% | Meeting requirement of<br>elongation under ASTM<br>D6319 |
| Ultimate Elongation<br>(after age) Minimum 14<br>MPa | Min 400% | Min 400% | Meeting requirement of<br>elongation under ASTM<br>D6319 |
| Freedom of Holes Meet<br>AQL 2.5 at G1 | Meet AQL 1.5 with<br>G1 | Meet AQL 1.5 with<br>G1 | Meeting requirement of<br>freedom of holes under<br>ASTM D6319 |
| Residual powder test<br>(Less than 2mg / glove) | Average powder<br>residue for each size:<br>S: 0.30 mg/glove<br>M: 0.31 mg/glove<br>L: 0.45 mg/glove | Contained less than<br>2 mg/glove | Meeting requirement of<br>powder residue under<br>ASTM D6319 |
| Primary Skin Irritation<br>(Surface-contacting, less<br>than 24 hours<br>duration) | Under the conditions<br>of study, not an irritant | Under the conditions<br>of study, not an<br>irritant | Yes, both are tested to be<br>non-irritant |
| Dermal Sensitization<br>(Surface-contacting, less<br>than 24 hours<br>duration) | Under the conditions<br>of study, not a<br>sensitizer | Under the conditions<br>of study, not a<br>sensitizer | Yes, both are tested to be<br>non-sensitizer |
| In Vitro Cytotoxicity<br>(Surface-contacting, less<br>than 24 hours<br>duration) | Under the conditions<br>of study, non-<br>cytotoxic | Not tested | The predicate device was<br>not tested for In Vitro<br>Cytotoxicity |
| Intracutaneous Reactivity | Under the conditions<br>of study, not an irritant | Not tested | The predicate device was<br>not tested for<br>Intracutaneous reactivity |

{20}------------------------------------------------

Image /page/20/Picture/0 description: The image shows the logo for AMMEX Malaysia SDN BHD. The logo features the word "AMMEX" in large, green letters. Below the word is the text "Malaysia SDN BHD" in smaller, blue letters. To the right of the word is a blue gear.

Discussion: The proposed device has different color to the predicate device.

20. Summary of Non-Clinical Performance Testing

The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.

| Name of the Test<br>Methodology /<br>Standard | Purpose | Acceptance Criteria | Results |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…